Vector by Divine Skin Solutions, Inc. (WARNING!)

Posted on April 25, 2010

Divine Skin Solutions, inc.

Divine Skin Solutions, Inc. sells a galvanic electric tweezer device under the name Vector for "an unbelievably low price of $199.95."

The Vector by Divine Skin Solutions should be avoided by all consumers. It makes illegal and unsubstantiated claims of permanent hair removal.

Contact information: ( = claimed to be incorrect by manufacturer. See Update, below.)

Address: 1983 Marcus Avenue Lake Success, NY 11042
Phone: (800) 443-4522
email: [email protected]
email: [email protected]
website: http://www.divineskin.com
website: http://www.smoothdivineskin.com (mirror site)

sales server: Five Star Advantage (fivestardavantage.com) (800) 443-4522
aka Tech-Ni-Comm, Inc.25006 Avenue Kearny Valencia, CA 91355 ([email protected] )

Alternate Contact Address: "Valery Smirnov" 8357 118th St., Apartment #5F, Kew Gardens NY 11415 (see below)
Alternate Phone: (718) 805-3569 (see below)

Names associated with this product

"Leo Smirnov"
"Leo Smironov"
"John Gubin"
"Valery Smirnov" (see below)
"Paul Condering" (see below)

Update one

On 12 April 2001, I received the following letter from " John Gubin, V.P. Marketing." My comments to them are in italics.

To Whom it May Concern:

We have noticed that you are making certain claims about our company. Please consider the following -

- The contact information you have is incorrect.

Please provide the correct contact information, and I'll include it.

- Valery Smirnov and Paul Condering do not exist in this company.

They are listed as contacts for your company. Please clarify their relationships to Divine Skin Solutions.

- You may search the FDA website and find that we are indeed registered with the FDA. We are making perfectly legal claims.

Your use of the FDA logo and reference to your FDA registration are illegal. References to FDA, in advertisements or other promotional materials for medical devices, are prohibited by the Federal Food, Drug, and Cosmetic Act and represent misbranding under section 502(a). The reference for this may be found under 21 CFR 807.97.

- Hair does not conduct electricity, the use of gel allows hair to conduct electricity.

I agree, but your competitor says hair does conduct electricity.

Please also note, that you have exactly 24 hours to remove any false claims regarding our company from your website. If this information is not removed by April 13th, 2001 at 5pm we will proceed with a lawsuit for punitive damages.

You have no grounds for a lawsuit. All of my information is factual. I look forward to receiving your updated contact information and your explanation regarding Paul Condering and Valery Smirnov.

Update two

On 13 April 2001, I received the following letter from " John Gubin, V.P. Marketing." My comments to them are in italics.

1. The correct contact information is - 1983 Marcus Avenue Lake Success, NY 11042

What is your office suite number? There are many business offices listed at that address.

2. Valery Smirnov and Paul Condering are not listed anywhere as contacts for our company. These two individuals simply do not exist in this company.

They are listed as contacts in your own company information. Please describe their relationship to Divine Skin Solutions. Are they assumed names used by people in your company?

3. Our website has been inspected by our representative at the FDA and she is fully aware of our use of the FDA logo. We are not making claims that our product is "approved" by the FDA, we are claiming that our product is registered with the FDA.

Your conspicuous display of your registration number with FDA logo appears to a reasonable consumer to be an endorsement by FDA. My information is based on comments by Steve Budabin at FDA's national enforcement office. Please tell me the name of your local FDA contact, and I will call her to confirm your claims. According to other cases like yours, conspicuous reference to your establishment registration implies FDA approval and is a violation of 21 CFR 807.39, which I have quoted below:

21 CFR 807.39

Misbranding by reference to establishment registration or to registration number.

Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

You can confirm this by contacting the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Drive, Rockville, Md. 20850 (telephone: 800-638-2041 toll free or 301-443-7491). All inquiries should provide complete information concerning the device and include a copy of the proposed labeling if the manufacturer contemplates shipping the device within the United States. Proposed labeling may be submitted in draft form and need not be printed.

4. Hair has electrical resistance and can conduct current. However, the voltages required for hair to conduct current will be lethal. Therefore, in practical terms hair cannot conduct electricity and electro-conductive gel is required to allow the current to travel down the hair shaft.

5. We have huge groungs for a lawsuit. You are stating that our product is a scam, and this information is not factual.

Published clinical data indicates that electric tweezers result in temporary removal of hair. In 1998 FDA stated there is no statistically significant scientific data indicating the device can achieve permanent removal of hair. If you have substantiation that it's permanent, you need to provide it.

I would like to remind you, that you have just a few more hours to remove this information from your website. We fully intend to proceed with a lawsuit.

I don't believe that you are familiar with our product and neither have you tried using it. Please be reasonable and do not cause our companies unnecessary trouble - a lawsuit will be expensive for both of us.

The burden of proof is on you to prove your claims of permanence, and you have not done so. Until you have provided substantiation for your comparative claims, your product is being promoted illegally.

I will update this as soon as I get a response.

Quotations from their sales site:

The site has a reference to FDA on their front page. Although they are registered, consumers should know they are not approved by FDA or endorsed by FDA. Implying FDA endorsement constitutes misbranding and violates federal law.

Proprietary Device Name: VECTOR
Owner/Operator: DIVINE SKIN SOLUTIONS, INC.
Owner/Operator Number: 9043298
Date of Listing: 10/03/00
Listing Status: Active
Establishment Operations: Manufacturer

The main page states says Vector's for you "if you are also tired of using products that make deceiving claims about hair removal," then goes on to make the following deceiving claims:

"We have developed a hair removal machine specifically configured for the home user to offer PERMANENT results.

"The Vector machine is just as effective as real electrolysis, yet does not use needles and requires minimal skill to be operated!

"you will find some straight talk about hair removal and how our Vector machine is a permanent solution to unwanted hair at a very affordable price.

The section on how it works claims: "The Vector machine works by simply grasping the hair with tweezers and applying a highly conductive gel with silver chloride. Without the electrically conductive gel this process would not work, as hair cannot conduct electricity. Applying silver chloride gel to the hair above the skin allows electrical current to pass over the non-conductive portion down into the hair follicle." This statement is repeated here: "Unfortunately, hair cannot conduct current." The electric tweezer scams need to get their story straight. Others (like GHR) claim the hair does conduct current.

Their ironically-titled truth page says: "If you have been fooled into purchasing those products by false advertising you may be reluctant to believe our claims as well. Rest assured that you will have real results and PERMANENT hair removal. The Vector is your professional electrolysis in a small box."

After the scam site's obligatory anonymous, unverifiable testimonials, the pricing page states:"The entire Vector electrolysis system comes with all you need to start immidiate [sic] treatments and is available for an unbelievably low price of $199.95."

Save your money. There is no published proof that electric tweezers can perform permanent hair removal.

AHRS 510(k) submission

Posted on April 25, 2010

 

AHRS submitted data to FDA claiming substantial equivalence to needle electroysis. On their fourth attempt, AHRS was cleared based on four unpublished, anecdotal, in-house reports with no peer review, discussing nine human subjects, four of whom were observed less than one hour.

Comparison to needle epilators, p. 1

pH data, p. 1

AHRS (WARNING!)

Posted on April 25, 2010

AHRS

Transdermal electrolysis: Totally temporary results
- or -   How to waste $4,400.00 needle-lessly!

Please see my page on Rejuvenu International Limited for the most recent information on this company.

 

There's actually no need for this page, since no transgendered woman has reported permanent facial hair removal using Transdermal Electrolysis alone. TE marketers say,"The TE System is permanent." I say, "Show me someone who proves it." They've had eight years to finish a client, but none have come forward. I feel the burden of proof is on Transdermal Electrolysis, and they have not met my only requirement.

However, to explain what it is and how they've been able to continue selling an unproven product, I've written up an exhaustive analysis of their inconclusive data and unethical business practices. I thought others may find my information to be a useful warning about falling for marketing hype.

(note: This appendix assumes you are familiar with hair physiology. If you aren't, please read my brief primer about hairs first. Also, when the word "permanent" is used in this document it is based on my working definition of "no method of hair removal needed for one year after final treatment.")

Introduction

I started seeing stuff about transdermal or "no-needle electrolysis" when I first signed on AOL a few years ago. I was going to write it off as a scam until I started seeing ads that they had gotten FDA approval to make claims of permanence. After some digging I was able to get more details on TE.

In 1990, North Carolina-based American Hair Removal Systems (AHRS) introduced a device similar to many electric tweezers already on the market. Later, they modified it slightly and renamed it "transdermal electrolysis," abbreviated TE. They call their device the TE System, and the current models of machine they sell are called the AHRS TE 429 or 629.

One TE sales site has the following price list:

  • TE #429 - $3495.00 --- 4 YEAR FULL WARRANTY (without Electronic Timer & Circuitry Meter)
  • TE #629 - $4395.00 --- 7 YEAR FULL WARRANTY (includes Electronic Timer & Circuitry Meter)

That's right. $3,500.00 for the cheap one; $900.00 more for a longer warranty and two more gizmos. If you think the price is astonishing, the truly amazing thing is that no transgendered woman has ever reported permanent hair removal using this device, yet AHRS manages to sell lots of 'em.

Here's how it's used: Basically, you put conductive gel on the skin (it's the stuff doctors smear on people getting hooked up to heart monitors). Then you treat the hairs with the original electric tweezers or with an electrified Q-tip (you think I'm kidding, right? I'm serious-- you put half a Q-tip in the machine and run electricity through it.)

The Q-tip gimmick was added after AHRS went on the market, probably to help separate them from other electric tweezers. There has been no clinical data showing the Q-tip works differently than the tweezers. The electric charge is supposed to be carried by the gel on the skin's surface to the hair root several millimeters below, where they claim the charge causes an electro-chemical reaction similar to galvanic electrolysis. The problem is that skin and hair are not very conductive, even using the gel, and any charge that reaches the papilla won't be strong enough to kill it.

The British TS group Looking Glass Society states: "It can readily be demonstrated from electrical theory and some simple bio-electrical measurements, that it is quite impossible to transfer enough energy into the follicle by this method to destroy it, even at the maximum voltage permitted by law."

I include a report which readily demonstrates just that below. Read Christa's primer on electrical engineering later in this appendix.

Transdermal electrolysis, the FDA and false advertising

Unfortunately, electric tweezer companies have found a marketing loophole which they use to claim permanence: a now-revoked policy known as the Guild standard.

Some background on the "Guild standard": in 1979 the International Guild of Professional Electrologists established a standard designed to help electrologists do a self-test to see how effective their treatment was. Although this standard was rescinded by the Guild several years ago because it was being misused by non-permanent hair removal marketers, those same marketers still use it to claim permanency. The definition of permanency as established in the rescinded Guild standard is "no hair regrowth of 40% of treated hair for up to 9 weeks." I don't know about you, but that doesn't sound permanent to me. Because the FDA has not established an official definition for "permanent" as applying to hair removal, they blindly went along with the Guild standard. Since then the FDA has begun to tell tweezer manufacturers to remove all references to FDA clearance. See my section on Guaranty Hair Removal for a typical FDA letter.

The end of this document has an excellent analysis written by Ted Molczan about how the FDA mishandled the AHRS claim.

Despite all this in-fighting, the bottom line for consumers is simple. Transdermal Electrolysis has not been proven permanent, despite being sold to consumers for over seven years. No transgendered woman has ever reported permanent facial hair removal using the TE System. Period.

A typical experience

In October, 1996, a fellow AOL member posted her experiences with TE System. She had purchased a machine for home use. She spent $3,400.00 for the smaller "professional" TE machine. Her initial reports were positive, but they stopped after a month or two.

In November, 1997, I sent her the following note:

Since it's been over a year since your first posts about your experiences with the TE System, could you please update me on your progress?

She wrote back that day:

You know I was just about ready to think about offering my machine for sale. Admittedly, I hadn't really been putting in a lot of hours and I wasn't going "by the book" in procedure all the time, but I just wasn't sure it was being effective enough to ever clear the whole beard.

Sadly, hers is the typical pattern:

  1. Buy the machine.
  2. Use it enthusiastically.
  3. Get excited about early results.
  4. Tell people how well it works.
  5. Lose interest when results aren't lasting.
  6. Forget to tell people you are no longer satisfied.
  7. Blame self instead of shoddy product.
  8. Throw it in the closet or try to unload it on someone else.

This happens with all of the non-permanent devices deceptively sold to consumers as permanent. Fortunately, with most electric tweezers, consumers are "only" out $80 to $200 dollars (although galvanic tweezers can run to thousands of dollars, too). People who try lasers end up losing hundreds, maybe thousands. With the TE System, losses are always in the thousands.

TE Website #1: Jackie's

[note: the links to this TE website do not work, because the site has been removed by the author as of March 8, 1998, in light of my scrutiny. More on this later. -- A.J.]

Jackie is a transgendered woman who has tried numerous hair removal methods. She is currently using Transdermal Electrolysis and says she has put up her website in the spirit of helping others judge for themselves if TE works.

In my advice in a nutshell, I say "I have received no report from any transgendered women who have had permanent* hair removal [* according to my "one year hairless" criterion] using any method other than traditional needle electrolysis. Anyone claiming otherwise is misinformed, speculating, or lying." Jackie falls into the second of these categories. She may seem well-intentioned, but Jackie admits she has never met any transgendered woman who has had permanent* results with TE. Her own treatment is not complete, either, so her own hopes of permanence* are merely speculation, too.

Jackie's web page about TE is titled "Transdermal Electrolysis - From Both Sides."

Like most AHRS sales material, Jackie mixes fact and fiction in a way that makes it all seem truthful. She starts with accurate information about hair physiology and the process of galvanic hair removal. Then she claims probe-based galvanic electrolysis is equivalent to TE's method. To support this claim of equivalence, she offers the the four pieces of data submitted by AHRS to the FDA when it allowed them to claim permanence based on a 9-week test. I summarize the data below, based on the original documents submitted:

1. Conductive Path Data

This is a very poor scan of a four-paragraph synopsis. A handwritten note adds that the test was completed down the road from AHRS offices at Sandhills Community College by William W. Rolland. The methodology is not fully described. Among the vital information omitted:

  • what sort of skin/hair (human or animal, live or dead, terminal/vellus, etc.)
  • the setting of their machine, indicating the amount of initial current.
  • The composition of their conductive gel.

Here's what they do say: They grasped the end of a hair with a stainless steel tweezer. They stuck an insulated electrolysis probe into a follicle, turned on the current, and measured the results.

Whoa, whoa, whoa! Wait a minute-- they used a needle, you ask? For their no-needle experiment? Here's the quote: "a needle inserted along the shaft of a hair into the dermal papilla."

I am not an FDA scientist, but even my rudimentary knowledge of the field is enough to see that their study is completely bogus.

2. Presence and amount of lye

This is another very poor scan of a four-paragraph synopsis. Someone stamped "Best Available Copy" on it. Best isn't very good, it turns out.

Their first study was full of holes, but it turns out this one's literally full of holes. Someone had taken a knife and literally cut out all the pertinent data. It looks like a censored military document. About a third of the document has been removed, including:

  • the number of test subjects
  • number of hairs treated
  • an entire sentence at the end of the first methodology paragraph
  • the entire second paragraph of methodology
  • part of the sentence describing the results

The second page has a table showing equivalent pH levels with the no-needle and needle devices. Of course, if this study used an inserted needle (as the first study did), then the results are moot, anyway. Since the methodology has been deliberately censored, there's no way to know if they cheated in the same way they did in their other test.

3. Microscopic analysis

The letterhead for this one bears a logo for the Academy of Dermology. No, that's not a typo. AHRS made up their own field of study. It's not Dermatology, that's Dermology. No address or phone number is available for this Academy, but I'll bet it's very close to the AHRS offices, if not even in the same office. Mark E. Chandler, M.D., longtime AHRS shill, has signed the analysis.

Chandler claims he analyzed six facial hairs of a genetic woman: three treated with AHRS 629, and three plucked hairs. Since female facial hair is not the same as male facial hair, this study is not applicable for our needs. Also, since Chandler does not discuss his methodology in any detail, they may have inserted a needle as they did in the first piece of evidence.

Even if it were applicable, I don't think it's reasonable to assume, as Chandler states it is, that a difference in the appearance of a hair's root means permanent hair removal has occurred. The only proof of that is long-term observation.

Survey data and "expert" opinions

Moving along to Jackie's survey data and expert opinions, we start with a 1997 publication from the International Organization of Non-Invasive Electrology. Again, I'd like the address and phone of this organization, which I have no doubt is another AHRS invention. This publication dances around permanence, saying TE "significantly reduces regrowth potential," but offering no clinical proof. They then chronicle important dates in AHRS history:

  • 1990-- FDA clearance to market
  • 1991-- Sales begin
  • 1992-- Doubled machine output to 1000 microamps
  • 1993-- They switched from tweezer and upped the power to 1500 microamps
  • 1994-- Findings are compiled from a coalition of scientists from such prestigious groups as the Dermal International Research Institute (again, let's see that address!). No mention of what they found.
  • 1995-- Third generation of TE system equipment tested. This is the q-tip and 2500 microamp gizmo available today
  • 1996-- A customer survey is commissioned. As expected, their survey methodology is not explained. I would like to know the satisfaction rate of consumers who are completed with treatment. As I've said earlier, people are initially satisfied with devices like these, and enthusiastic. In all cases I've seen, this eventually fades. I want to see people who are done and have had permanent results. I do not believe they exist. Also in 1996, twenty "experts" submitted letters about the TE System. Jackie includes scans of five of the expert letters:
  1. Dr. Elyahu Tamir of Vienna. Whether that is Vienna VA, or Vienna Austria can't be determined-- the return address has been altered and made illegible. Tamir never mentions seeing permanent results using the TE System.
  2. An unknown doctor whose name has been made illegible by altering the letterhead and signature.The text states he's a member of the American Academy of Dermatology, and attended University of Puerto Rico Medical School. He's pleased that his TE clients "keep coming back," indicating they're not getting permanent results. Never mentions seeing permanent results using the TE System.
  3. An unknown TE practitioner, on letterhead from Permanent Hair Removal, Inc. of Cary, NC. Dated March 18, 1997. The address and phone have again been altered, as has the name of the author. Never says any clients have received permanent results using the TE System, only that they are likely to reach their goal of permanent hair removal. This speculation means nothing.
  4. Dermatologist Gordon Vice, M.D., based in "a town south of Nashville." Dated June 28, 1996. Never mentions seeing permanent results using the TE System.
  5. Valinda Riggins-Nwadike, M.D. OB/GYN. Dated November 14, 1996. She was getting treatment at Your Touch Salon for Hair Removal of Raleigh, NC. She had only been using TE for six months at time of writing. Never mentions seeing permanent results using the TE System.

I assume the other 15 experts' letters are just as unimpressive.

The FDA letter

Jackie asks if we want to see the FDA letter of recommendation

By all means, let's look. I have already debunked all of their evidence above, but some of you may be interested in how they used it to fool the FDA. Wherever the letter mentions something bogus which I've disproven, I supply a link to that point on my page. Here is the letter verbatim:

  • DEPARTMENT OF HEALTH & HUMAN SERVICES
  • Public Health Service
  • Food and Drug Administration
  • 1390 Piccard Drive
  • Rockville. MD 20850
  • Date: August 9. 1990
  • From: Paul Tilton, HFZ-410
  • To: The Record
  • Re: K892514/C AHRS Epilator 629
  • American Hair Removal System, Southern Pines, NC

INTENDED USE

The-AHRS Epilator 629 is an electrolysis device that is intended to destroy the roots of unwanted hair with an electrical current for the purpose of permanent hair removal. lt is accomplished by the destruction of the dermal papilla and the surrounding germative cells in the lower portion of the hair follicle.

DEVICE DESCRIPTION

The AHRS Epilator 629 is a galvanic tweezer-type epilator. The device is claimed to be substantially equivalent to pre-enactment galvanic needle-type epilators. The major technological difference between the AHRS Epilator 629 and the pre-enactment device is that the AHRS device utilizes a tweezer, rather than a needle, to deliver galvanic current down the hair shaft. The conduction of current down the hair shaft is facilitated by application of a highly conductive electrolytic solution onto the hair. The solution used is currently marketed as a multipurpose electromedical (e.g., ECG) electrode solution. Galvanic (needle-type) epilators have been used to remove hair as early as 1875 and are currently regulated by FDA as class II devices. They are considered to be reasonably safe and effective for permanent hair removal when used by a trained electrologist.

Because of the technological differences between the 2 device types, the question of device effectiveness is raised. To demonstrate the equivalence of the AHRS Epilator to needle-type electrolysis devices, AHRS submitted results of several studies. The first study was conducted by Mark Chandler, M.D. , a dermatologist contracted by AHRS. It involved a comparison of pH level of the hair root on 3 test subjects following epilation with either, 1) the AHRS Epilator, 2) a galvanic needle-type epilator, and 3) manual tweezing with no prior treatment. Six hairs were removed from each test subject using the 3 different methods. Results demonstrated that the average pH of both the hair roots removed by the AHRS device and the galvanic needle-type epilator were pH 11 (with a range for both devices of pH 7 to pH 13), while the pH of the tweezed hairs were all pH 7 or less. The pH of the conductive gel is ph 5.5. From this data Dr. Chandler concluded that the electrolysis reaction is occurring with both of these devices and that these devices produce an equal amount of NaOH as a product of electrolysis.

A second study was conducted by William W. Rolland, an instructor in electrical engineering at Sandhills Community College, Pinehurst. NC. This study was performed to determine to what extent current is made to flow within the dermal papilla when one of the electrodes is a tweezer which grasps the hair shaft. In this study the negative electrode was the tweezer from the AHRS device which grasped the hair shaft which had bean coated with a conductive solution. The positive electrode was a needle inserted along the shaft of a hair into the dermal papilla. The shaft of the needle was insulated so that contact was made only at the base of the hair, within the dermal papilla. Results from several trials demonstrated that the average current produced in the dermal papilla was 470 microampheres. Mr. Rolland concluded that a conductive path exists along the hair shaft and through the dermal papilla and that the AHRS Epilator 629 device is capable of producing a current of approximately 470 microamps along this path.

In addition, a controlled clinical trial was conducted by Dr. Chandler, which compared the effectiveness of hair epilation using a galvanic needle-type epilator and the AHRS Epilator 629. The study followed the standard procedures established by the International Guild of Professional Electrologists. Inc. for evaluating the effectiveness of epilators for permanent hair removal. FDA has not established its own guideline for testing for effectiveness in permanent hair removal, nor defined "permanence". Five test subjects (4 females and 1 male, ranging in age from 21 to 53 years) were treated, using the Guild's test procedures. The procedure involves removing 50 hairs from the subject's anterior shin within a concentrated area, using the needle device (control) and doing the same in an area in close proximity, using the test method. Test and control sites are examined weekly for 9 weeks. Hair appearing within 14 days were considered anagen hair (which were charted and not considered regrowth). Regrowth hair is hair which emanates from treated follicles. After 9 weeks, results were recorded. From the study results, Dr. Chandler concluded that both of the devices achieved equivalent results in removing hair and both complied with the definition set forth by the International Guild of Professional Electrologists, Inc. as being effective, since they both removed permanently at least 40 percent of the hairs on one treatment in this study.

Dr. Chandler also performed a microscopic comparative analysis of hairs epilated with the AHRS Epilator 629 (test) vs. hairs manually tweezed with no prior treatment (control). 35 mm photographs were taken of each slide and are included in the submission. Microscopic examination revealed a difference in the appearance of test hair vs. control hair. Hairs epilated with the test device lost the normal hair matrix. The normal structure of the papilla had been destroyed and the normal follicular layers were not in evidence. In contrast, the papilla and follicle layers of the control (manually tweezed) hairs appeared normal. Dr. Chandler concluded that the follicle and papilla of the treated hairs were destroyed and could not sustain growth of the hair.

Comparison of labeling associated with the AHRS device and predicate needle-type epilators, demonstrate that labeling claims are comparable, with one exception. Use of the AHRS Epilator 629 is claimed to be painless. There is no evidence that needle-type epilators are promoted as painless. There is no objective data in the document to supported the painless claim. I discussed this issue with Mr. Lee Cole, in a telecon on 8/9/90, and he stated that he would remove the claim of "painless" from his advertising literature.

RECOMMENDATION

I believe that it is reasonable to conclude that results of the testing, as described above, demonstrate that the AHRS epilator 629 is substantially equivalent to predicate galvanic needle-type epilators, in terms of effectiveness. Therefore, I recommend that the device be deemed substantially equivalent to predicate galvanic needle-type epilators.

Photographic evidence

Finally, Jackie allows you to "see for yourself," with pictures of treated hairs.

As I said earlier in my discussion of data item #3, I don't think it's reasonable to assume that a difference in the appearance of a hair's root means permanent hair removal has occurred. The only proof of that is long-term observation. If TE is permanent, show me someone who will say they had permanent results.

Conclusion

Jackie concludes her case, saying: "There is data beyond that of the 9 week comparitive [sic] study to help support the TE systems claim of permanent hair removal." I find this data shoddy, vague and inconclusive. If they want to be taken seriously, AHRS needs a study performed by an independent researcher who was able to achieve permanent results. Their evidence does not prove permanence by any stretch.

I especially like that Jackie's TE site uses this graphic of a guy with a full beard. Maybe the caption should read, "I paid $4,400.00 for an AHRS TE 629, and I still have a beard!"

This is an open challenge to Jackie: link my page to your site. I have linked mine to 12 of your pages, since I have clearly shown that neither you nor AHRS have grounds to claim permanent hair removal.

OK, so after wasting a weekend of my life debunking every single point and piece of evidence that AHRS has made public, it still comes down to this:

No transgendered woman has ever reported permanent facial hair removal using the AHRS 629 Transdermal Electrolysis System. Until someone does, I recommend investing in the only proven permanent method of hair removal: traditional probe electrolysis from a practitioner recommended by a TS who is done and happy.

As Jackie says at her site, judge for yourself.

TE Website #2: _____'s

[note: As with the site revied above, the links to this TE website do not work, because the site was taken down by the author between March 4 and March 8, 1998. Also, the website author and person who wrote the sales material described below has asked me to remove her name from this page. Apparently, she no longer wants to be associated with some of her statements. While I have granted her first request and replaced her name with "_______", I will not grant her second request to take down information she has been disseminating for several years, just because her unchallenged claims are finally being scrutinized. More on this later. -- A.J.]

_______ is another transgendered woman who sells Transdermal Electrolysis equipment. Her website contains a copy of the sales literature she sends to other transgendered women. She says her information is taken primarily from actual AHRS TE System Owners Manuals, with additional information provided by the manufacturer and AHRS associate Dr. Mark Chandler. She supplements this with personal experience.

AHRS marketers cleverly mix truth and speculation in a way that makes it all look like unassailable truth. Much of _______'s information is completely true, but I take issue with her claims of TE System's permanence.

Don't believe the hype

People want their hair removed as quickly, painlessly, safely, and cheaply as they can. They also want it gone forever. In addition, especially for closeted members of the TG community, discretion is often imperative. Like all hair removal marketers, AHRS knows that touting these benefits wherever possible will resonate deeply with consumers.

Thus, _______ cites all the qualities many TG women find so tempting:

  • Use it privately and conveniently in own home
  • Only cost is machine (not figuring in expendable supplies like the four solutions required in the treatment process. Also, not figuring in the value of the consumer's time.)
  • Less painful
  • Safer
  • Faster
  • Permanent

All of these are brought up in comparison to traditional needle electrolysis. I cannot refute some of the points. The rest are not of concern to me, because I believe that the most vital comparison AHRS makes to needle electrolysis is permanence. If the TE System is not permanent, the other points make no difference.

Throughout her sales material, _______ confidently describes TE as permanent :

  • "The TE System, when used correctly, can permanently remove your unwanted hair."
  • "...a less painful, safer, effective way to permanently remove unwanted hair."
  • "Transdermal Electrolysis can achieve permanent hair removal without the side effects of needle electrolysis."
  • "The TE System is a non-invasive, safe method of permanent hair removal."
  • "20 experts who attested to permanent, safe and increasingly efficient results regarding the TE System."
  • "Using the TE System, it is possible to permanently disable the hair follicle without tweezing the hair ..."
  • "...will allow YOU to determine if Transdermal Electrolysis is the best option for permanent removal of your unwanted hair."

Since she has led people to believe that TE is permanent, I will focus on these claims as I did with the information Jackie supplied.

Synopsis of _______'s sales info

Her info starts off fine: a history of TE, a history of traditional electrolysis, how TE devices are used. All pretty accurate. Then things start getting messy. In her section on why a device that's faster, cheaper, less painful, easier, safer, and permanent has not taken over the market, she flogs the dead horse about how a powerful cartel of financially motivated needle electrologists have conspired to keep AHRS down. Hmm.

Her next section on how long TE will take has no answer, stating that there are too many variables. She does quote how long it takes for needle electrolysis, however. Now, if she quotes an average completion time for electrolysis, why is there not an average for TE?

Next is an important section, for which I will merely quote _______ verbatim:

HOW DO RESULTS WITH THE TE SYSTEM COMPARE TO THAT OF NEEDLE ELECTROLYSIS?
To date, there has been no controlled study outside of those conducted by the manufacturer that answers this question.

_______ then cites the FDA approval, the 20 expert letters, and the TE survey, all debunked earlier. Then she flogs the other dead horse: the only reason people don't achieve satisfactory results with TE is that they were not following the procedures correctly.

What are those procedures? _______ describes the 14 easy steps, some of which are repeated up to 40 times:

  • Use AHRS cleansing squares ($10/package) to clean the area with AHRS cleansing solution ($20/bottle)
  • Apply AHRS Pre-Treatment Gel ($20/bottle) to exfoliate
  • Apply a very warm, moist towel
  • Dry the skin
  • Insert half a Q-tip into the probe
  • Apply a 1/4" glob of AHRS Electrode Gel ($35/bottle) onto the skin area to be treated.
  • Place Q-tip in gel and treat
  • Repeat , until you've made 10-20 circles in this fashion
  • Retreat all circles
  • Wipe off gel
  • Apply a very warm, moist towel for one minute
  • Dry the skin
  • Apply AHRS EZ Tweeze moisturizing cream ($20/bottle)
  • Remove hairs: let fine hairs fall out on their own.Tweeze medium and coarse hairs in the order treated.
  • She includes additional instructions on two methods for transgendered women
    • Shave before treatment and let the hairs fall out over 6-8 weeks
    • Treat then tweeze, which she claims is more effective

These are explained in the instruction manuals and videos that come with your purchase, or you can travel to rural North Carolina for a training seminar for additional money.

A third-party expert

_______ then cites Dr. Nancy Ledins, who is described as "not in any way affiliated with AHRS."

I have quoted three pertinent passages from Dr. Ledins' testimonial:

RESULTS: There is ample "anecdotal" evidence (e.g. satisfied clients) but no independent hard data. This is not to say that anecdotal "testimonials" are not valid, but that, to date, there has not been a controlled study done by a resource outside of the America

Sofblend (Tapeography, Ltd.)

Posted on April 25, 2010

Sofblend (Tapeography, Ltd.)

Toronto-based Sofblend originated in 1998 as a division of Tapeography, an electronics company that was founded in 1987.

The Sofblend T-80 needle epilator is available for use in the US.

On January 16, 1996, the FDA reclassified needle epilators, so devices like the T-80 are allowed to be marketed in the US without submitting a 510(k).

The FDA offers voluntary registration of new epilators, and the Sofblend T-80 is registered under file B039421.

It may be used for permanent hair removal by electrologists in any licensed or unlicensed state.

(I apologize for a previous statement on this page that may have suggested that the Sofblend T-80 has not been cleared by the FDA.)

Contact information

Available devices

Epilator name G B T FT MNG
Sofblend T-80 X X X X  

Key to features:

  • G = Galvanic
  • B = Blend
  • T = Thermolysis
  • FT = Flash Thermolysis
  • MNG = Multiple-Needle Galvanic

Notes:

The Sofblend epilator uses either regular or Uni-Probe needles.

Old website/email:

http://www.tapeography.ca/
[email protected]

Sterex Electrolysis International

Posted on April 25, 2010

Sterex Electrolysis International, Ltd.

Sterex are a UK based manufacturer of Electrolysis products. Their products include epilators, wet products, and sterile disposable needles, which sell in over 40 countries.

Contact information

  • Address: 174 Kings Road, Tyseley, Birmingham, B11 2AP, UK
  • Telephone: +44 (0) 121 708 2404
  • Fax: +44 (0) 121 707 0028
  • website: http://www.sterex.com
  • email: [email protected]

Available devices

Sterex also manufactures four needle epilators, which are exempt from premarket notification. On 16 January 1996, FDA reclassified needle epilators and no longer requires them to submit 510(K) data.

  • Sterex SX~T (Thermolysis / Diathermy Epilator)
  • Sterex SX~B (BLEND EPILATOR)
  • Sterex SX~A (Automated Thermolysis/Diathermy Epilator)
  • Sterex SX~G (Galvanic Epilator)

Sterex disposable needles:

  • Sterex Sterile Disposable Electrolysis Needle (FDA 510 K952611 Cleared 10/18/95)

Stoltronic Systems, Inc.

Posted on April 25, 2010

Stoltronic Systems, Inc.

Stoltronics had an epilator cleared in 1982. On October 12, 1999, founder Steve Stoltenberg told me they were moving manufacturing to Scotland and working on a website. More as it becomes available.

Contact information

Available devices

Epilator name FDA 510(k) Cleared G B T FT MNG
Stoltronics LRS K813637 02/04/82     X    

Key to features:

  • G = Galvanic
  • B = Blend
  • T = Thermolysis
  • FT = Flash Thermolysis
  • MNG = Multiple-Needle Galvanic

Notes

Synoptic Products/Arand Ltd.

Posted on April 25, 2010

Synoptic Products

Synoptic Products is the importer for Ballet needles for the United States, and as such is required by FDA to obtain 501(k) clearance prior to importation. This is standard procedure for importers of medical devices. Maker of Ballet sterile disposable needles.

Ballet Technologies Ltd
Brunswick House, Rose Lane,
Biggleswade, Bedfordshire, U.K. SG18 ONB
Tel: (44) (1767) 225 092;
Fax: (44) 01767 225 091;
E-mail: [email protected]

Web site: http://www.balletneedles.com

Information provided by Joe Asch, President, Ballet Needles on 9 April 2005.

These are very commonly used. For more on choices in electrolysis probes, click here.

Information was updated based on a letter from Synoptic president James Paisner on 16 February 2001.

 Leo Unlimited, Inc.

Posted on April 25, 2010

Leo Unlimited, Inc.

Little is known about this manufacturer at this writing.

Contact information

  • Address:
  • Telephone:
  • Fax:
  • website:
  • email:

Available devices

Epilator name FDA 510(k) Cleared G B T FT MNG
Epitron Super K834572 04/23/84 X X X X  
Epilot 80 S (tm) K833946 04/04/84 X X X X X

Key to features:

  • G = Galvanic
  • B = Blend
  • T = Thermolysis
  • FT = Flash Thermolysis
  • MNG = Multiple-Needle Galvanic

 

Notes

 

 

Lucy Peters International, Inc.

Posted on April 25, 2010

Lucy Peters International, Ltd.

Lucy Peters is a New York based manufacturer and practitioner with 9 locations. Peters' proprietary Integrated System is a flash thermolysis device used in conjunction with flexible, insulated, bulbous-tipped probes.

Contact information

Available devices

Epilator name FDA 510(k) Cleared G B T FT MNG
LPS 33

Precision Electrolysis, Inc.

Posted on April 25, 2010

Precision Electrolysis, Inc.

Makers of the Uni-Probe needles. Precision also makes the Auto-Blend fully automatic blend and thermolysis epilator.

Contact information

Can you please include our supplier website on the hairfacts site (www.electricspa.com) We offer all of our precision products on-line at great prices to professional electrologists.

Available devices

Epilator name
Uni-Probe Needle
Auto-Blend Epilator

Key to features:

  • G = Galvanic
  • B = Blend
  • T = Thermolysis
  • FT = Flash Thermolysis
  • MNG = Multiple-Needle Galvanic

Notes

Uni-Probe Needle was cleared by FDA as K894771 on 21 August 1989.

On January 16, 1996, the FDA reclassified needle epilators, so devices like the Auto-Blend Epilator are allowed to be marketed in the US without submitting a 510(k).