Global Tronics International
Global Tronics makes cosmetic devices sold to salons. This page only discusses their electric tweezer hair removal device sold under the name Hair Tronics.
The Hair Tronics device manufactured by Global Tronics International should be avoided by all consumers.
Here is an example of violative promotional material from a salon which purchased the device and promotes it based on Global Tronics’ claims that FDA lists the device as permanent hair removal:
“At Arleens we use Hair Tronics a FDA listed permanent non-invasive method of gently removing unwanted facial and body hair . This technique is accomplished by means of the custom-designed tweezers utilizing gentle falvanic current. Hair removal without pain. Permanent Hair Removal 15 minutes $12.50, 30 minutes $25.00"
Here are a couple of non-US examples:
http://www.plazaboricua.com/ileanairvine/espanol/tecno_info.htm (Puerto Rico)
In 1998 the U.S. Food and Drug Administration (FDA) stated that "there is no statistically significant scientific data available at this time to support promotional claims of permanent or long-term removal of hair through use of the device."
These devices have been available since 1959 with no published clinical data indicating they can achieve permanent hair removal as that term is generally understood by consumers.
Contact: Michael Mantell Jr.
Address: VISUAL PROOF 123 Windsong St Thousand Oaks, CA 91360-2873
Telephone: (805) 492 -8946
Address: Masry & Vititoe, 5707 Corsa Avenue, Second Floor Westlake Village, California 91362
Telephone: (818) 991-8900
Fax: (818) 991-6200
Contact: EDWARD L. MASRY, ESQ.
email: SOVEIDA RODRIGUEZ <SRODRIGUEZ@MasryVititoe.com>
Global Tronics International threatens legal action
After putting up a consumer warning about this electric tweezer scam, I received a threat from Ed Masry.
Masry is best known as the retirement-ready ambulance-chaser* who was played with bumbling charm** in the film Erin Brockovich.
Below is our correspondence, with Masry’s sloppy misspelling left in place.
May 18, 2004
VIA CERTIFIED MAIL
Re: My Client: Global Tronics International
Dear Ms. James:
Be advised that this office represents Global Tronics International in regards to your continual illegal statements about their products. Attached hereto you will find a memo to the record of the FDA showing that their devise [sic] permanently removes hair. Your reference to their product as a scam will not be tolerated by my client or this office. You shall immediately within 24 hours remove permanently any mention of Global Tronics International from your website, or rest assured that no later than one week from this date, you will be appropriately sued in federal court.
Trusting I have made myself quite clear, I remain
Very truly yours,
MASRY & VITITOE
EDWARD L. MASRY
cc: Global Tronics International
I responded immediately upon receipt:
Your evidence that Global Tronics International has FDA clearance to claim its tweezer type epilator achieves permanent hair removal was not attached to your email.
In 1998 the U.S. Food and Drug Administration (FDA) stated that "there is no statistically significant scientific data available at this time to support promotional claims of permanent or long-term removal of hair through use of the device." (FDA Docket 97N-0199).
Please send evidence that your client’s device has been cleared by FDA to make claims of permanent hair removal, or I will assume your threats of a SLAPP suit are groundless and without legal merit.
A Masry flunkie later sent the purported evidence, which was some sort of internal memo written 12 years earlier.
I also contacted FDA about Global Tronics thanks to Masry, and FDA sent this reply on 19 May:
If you carefully read the Reclassification FR (97N-0199) you will see that FDA agreed that "there is no body of significant information establishing the effectiveness of the device to permanently remove hair." Furthermore FDA stated that the agency still supported the down classification of the device since we could address claims of "permanent" hair removal via the misbranding provisions of the Federal Food Drug and Cosmetic (FFD&C) Act. It is my understanding that any language supporting "permanent hair removal" whether in a 1992 510k clearance and/or in a 1992 Listing report would be nullified by the subsequent (1998)reclassification regulation. Do you have any literature or web link illustrating that Global Tronics is actively promoting their product as a permanent hair removal device. If so this product may be misbranded under the FFD&C Act. I have directed this to our Office of Compliance for any further action they deem necessary. Do not hesitate to contact our office for any further clarification.
I immediately sent FDA several examples of violative promotional materials from Global Tronics per FDA’s request. I would not have done this had Mr. Masry not threatened me with a federal SLAPP suit.
I then made two more attempts to get Mr. Masry to provide legitimate evidence of his client’s alleged FDA clearance following receipt of my letter from FDA. Once Masry finally wandered into the office in the late afternoon, he shot back with yet another threat:
Dear Ms. James:
You have decided, without any research, to call my clients a "scam". I am not sending you any information, but I am making it very clear that next time you print anything regarding my client, this office will, within five working days, file an action in Federal Court for libel, unfair business practices, etc.
I am not going to do your research. Unless you comply with my request, rest assured that the next document you get from me will be a Federal Subpoena.
Trusting I have made my position quite clear, I remain
Very truly yours,
MASRY & VITITOE
I responded thus:
I am once again requesting that you provide evidence that the Hair Tronics device is substantially equivalent to predicate devices cleared by FDA as permanent. This claim does not match the information I have in my records or information provided by FDA.
After corresponding with FDA today, it is my understanding that any language supporting "permanent hair removal" whether in a 1992 510k clearance and/or in a 1992 Listing report would be nullified by the subsequent (1998) reclassification regulation.
I am making a good faith attempt to resolve this matter, yet you continue to threaten me with a SLAPP suit.
I have done plenty of research on these devices and have concluded that your client’s device is in my opinion a scam.
In your zeal to threaten me, you have now brought your client’s activities to the attention of federal authorities. If I were Global Tronics, I’d consider a malpractice suit. Please provide me with your client’s address so I can share this development with them directly.
How to sue Global Tronics
If you have been scammed by someone selling this device or treatments with it, please contact me, and I will send instructions on how to sue them in small claims court.
From FDA’s device listing database:
Device Classification Name EPILATOR, HIGH FREQUENCY, TWEEZER-TYPE
Regulation Number 878.5360
510(k) Number K915845
Device Name HAIR TRONICS MODEL HT8000
Applicant GLOBAL TRONICS INTL., INC. 2626 LAVERY CT.SUITE 301 NEWBURY PARK, CA 91320
Contact MANTELL, JR.
Product Code KCX
Date Received 12/26/91
Decision Date 07/29/92
Decision Substantially Equivalent
Classification Advisory Committee
General & Plastic Surgery
Review Advisory Committee
General & Plastic Surgery
Statement/Summary/Purged Indicator Statement/purged 510(k)
Establishment Name: GLOBAL TRONICS INTL., INC.
2899 AGOURA RD., SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Establishment Operations: Manufacturer
Owner/Operator Number: 9038966
Owner/Operator: GLOBAL TRONICS INTL., INC. 2899 AGOURA RD., SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Official Correspondent Firm: GLOBAL TRONICS INTL., INC. 2899 AGOURA RD., SUITE 139 WESTLAKE VILLAGE, CA 91364 US
Establishment Status: Pending registration
Date of Registration Status: 09/07/99
Owner/Operator Phone Number: 888-387-6642
Official Correspondent Phone Number: 806-492-8396
Date Initial Registration Received: 09/02/99
Official Correspondent Name: MR. MICHAEL MANTELL
Note that statements on this page make no claims regarding the Visual Proof microdermabrasion device sold by Global Tronics International. This site only deals with epilation.
* Michael O’Sullivan Washington Post
** Bob Longino, Cox News Service