For years, Rejuvenu has been making claims that their SuperPhaser
Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause
permanent hair removal. Rejuvenu claims about Super Phaser Gold
are untrue and in violation of federal regulations.
Full text of the Rejuvenu letter follows the scan, with highlights
in bold.
October 17 2001
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
H. Lee Cole
Chief Executive Officer
Rejuvenu International Limited
230 North Bennett Street
Suite 101
Southern Pines, North Carolina 28387
Re: Hair Removal Devices
Dear Mr. Cole:
The Food and Drug Administration (FDA) has reviewed your letter,
dated May 23,2001, responding to our April 2, 2001, letter concerning
promotional materials on your website at http://www.ihrsinc.com
for the Super-Phaser Gold and Transcutaneous Electro Patch System.
We received your response on August 16, 2001.
The AHRS Epilator 629 was cleared under K892514 as a galvanic
tweezer-type epilator, along with claims for permanent hair
removal. Since our April 2 letter was sent, we further reviewed
and discussed the permanent hair removal claim with our Office
of Device Evaluation (ODE). We agree that the permanent hair
removal claims for this device were in accordance with a definition
that was commonly used in the context of hair removal at the
time that the clearance was granted. Therefore, claims for permanent
hair removal are allowable for this device, but these claims
are limited to the tweezer epilator mode.
Our August 2001 review of your current website at http://www.ihrsinc.com
shows that it is essentially unchanged from the website we initially
reviewed in April 2001. We note that the name of your company
is now Rejuvenu International Limited.
Your website’s home page indicates “TRANSCUTANEOUS
ELECTRO PATCH SYSTEM...”painless.” A picture of the
Super-Phaser Gold is also shown. The various website links and
sublinks, e.g., http://www.ihrsinc.com/superphasergold.asp,
http://www.ihrsinc.com/features-benefits.asp, http://www.ihrs.com/articles-transpatch.asp
and http://www.ihrsinc.com/faqs.asp take the reader to discussions
on the Super-Phaser Gold and the Transcutaneous Electro Patch.
The Super-Phaser Gold is claimed to be a "high-quality
FDA Class I medical device indicated for permanent removal of
unwanted facial and body hair," and features 4 different
methods of treatment: hands-free transcutaneous, continuous,
transdermal, and tweezer. It states that the Super-Phaser Gold
"is capable of using up to 12 Transcutaneous Patches at
one time." The transcutaneous Hair Removal patch features
three hair removal modalities "integrated into the same
Class I, FDA approved medical device," and the system is
virtually "hands free." Other claims made include,
but are not limited to, "the Super-Phaser Gold is the first
hair removal product that can permanently disable large numbers
of hair follicles without the use of needles or probes. This
technological breakthrough is called Transcutaneous Electrolysis...,"
"Just recently, Lee Cole introduced his latest permanent
form of hair removal, Hands Free Transcutaneous Electrolysis...
With non-invasive procedures like Transcutaneous Electrolysis
being developed, painless and permanent hair removal is now
possible." Additional claims include there is no risk of
infection pitting, or changes of pigmentation and no pain. There
are several statements on the website indicating that FDA clearances
or approvals have been obtained.
In 1995, you submitted a 510(k)955584 for the AHRS Surface
Electrolysis System, a modified “Patch” epilator device
that you apparently believed was a modification requiring a
new 510(k) and FDA clearance. However, ODE had numerous questions,
and could not clear the device. These concerns were discussed
with you, including a request to provide valid scientific data
that demonstrated the device was substantially equivalent in
terms of performance and adverse events. It was indicated that
the Agency believed that this technology might be significantly
different from the needle and tweezer epilators and the present
protocol you submitted might not adequately characterize these
parameters. Your device applies diffuse energy to the site,
whereas needle and tweezer epilators apply directed energy.
ODE indicated a new protocol should be developed. ODE sent you
a “Cannot Respond” letter, notifying you that your
submission was being withdrawn from the system and that all
information should be re-submitted and assigned a new 510(k)
number. You supplied no additional data or information.
Absent FDA clearance, you have chosen
to market this device, and include claims that imply FDA clearance
or approval. It appears that you have made a decision independent
of regulatory review that your devices are equivalent to the
cleared device.
ODE has reviewed your current response and continues to disagree
with your assessment that your devices are equivalent to the
cleared tweezer-type epilator or that the basic technology or
mechanism of action has not changed. In accordance with 21 CFR
878.5360, the energy provided at the tip of the tweezer-type
epilator used to remove hair may be radio frequency, galvanic
(direct current), or a combination of radio frequency and galvanic
energy. As noted in K892514, “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.” This
definition and clearance does not include energy delivered through
electrodes, cotton-tipped probes, or by any other methods. There
are no premarket notification clearances, for any indication,
for so-called hands-free transcutaneous, transdermal cotton-tipped
applicator probes, or continuous hair removal. In
your response, you indicate that the difference in the device
is that the operator uses a different apparatus to apply the
galvanic current which contact the gel instead of the tweezers.
If you wish to pursue claims for the Super-Phaser Gold and
Transcutaneous Electro Patch System, you will need a new 510(k).
This requires that all information/data to support the claims
be submitted as a new 510(k). The discussions you presented
in your May 23, 2001, response, and any other data, should be
included in the new 510(k). You should submit all data that
you believe supports your claims. You should submit all data
that you believe supports your claims. If you should decide
to submit a new 510(k) to ODE, and/or have questions concerning
the 510(k) submission, please contact Mr. Stephen Rhodes, ODE,
at 301-594-3090.
You have indicated that you were not aware that references
to FDA approval were in your marketing literature and you have
instructed your marketing representatives to remove any references
to the FDA. However, the same statements indicating that the
devices are FDA cleared or approved remain on your website.
Your firm has received FDA clearance for the AHRS galvanic tweezer-type
epilator only.
Additionally, appropriate data have not been submitted to support
claims of no risk infection, pitting, changes of pigmentation,
including any claims of no bruising, no scabbing, or no scarring,
or that the procedure is painless. We requested evidence to
support these claims; no response was received. The “painless”
claim was previously discussed with you in the August 9, 1990,
memo from the FDA’s Paul Tilton. You provided this letter
as Exhibit 1 in your response. The following statements are
taken from this 1990 letter: “Use of the AHRS Epilator
629 is claimed to be painless....There is no objective data
in the document to support the painless claim. I discussed this
issue with Mr. Lee Cole...and he stated that he would remove
the claim of “painless” from his advertising literature.”
The “Products/Super-Phaser Gold” link has an additional
link “Articles about Hair Removal,” that includes
a link to an article entitled “Comparison of Currently
Available Permanent Hair Removal Methods.” The material
at this site, http://www.ihrsinc.com/articles-comparison.asp,
discusses the Epiljet. It is stated that “Epiljet is now
available in several countries (it has not received US FDA clearance).”
We have confirmed this with ODE. You cannot legally promote
an unapproved device in the US.This article also includes a
section on laser hair removal. It is implied that only ruby
lasers have been cleared for marketing; this has not been true
for several years. ODE states that presently, ruby, Nd:YAG,
diode, alexandrite lasers and intense pulse light sources have
all been cleared for hair removal and most of these also have
the “permanent reduction claim.” Regarding laser treatment
of dark pigmented skin, several of these devices have been cleared
for treatment of dark pigmented skin. Several companies have
clearances that allow claims regarding the treatment of skin
type I-VI and/or for the treatment of suntanned sites. In fact,
FDA has cleared several devices for treatment of a condition
called pseudofolliculitis barbae that is most common in African
Americans. Finally, regarding the ThermoLase, ODE is not aware
of any adverse effect reports or claims that the carbon powder
lotion remains after treatment and/or becomes permanent. Unless
you can provide data to substantiate the claims associating
the topical lotion with possible adverse effects, they should
be deleted. We caution you that representations in the labeling
of a device that are false or misleading with respect to another
device may render your device misbranded in accordance with
21 CFR 801.6.
In summary, we have advised you of the premarket notification
processes and the cleared uses of epilators. We have pointed
out the objectionable information on your website, and the reasons
why the material is objectionable. Your promotional claims must
be limited to the cleared intended uses. The modifications made
to the cleared tweezer epilator change the intended uses of
the device as described under 21 CFR 807.81(a)(3)(ii) and make
it subject to the premarket notification requirements. Continued
promotion of the Super-Phaser Gold System and Transcutaneous
Patch as discussed above may misbrand and adulterate your device
within the meaning of sections 502(o) and 501(f)(1)(B) of the
Act, respectively.
Sincerely yours,
Patricia L. Jahnes
Consumer Safety Officer
Promotion and Advertising Policy Staff
Office of Compliance
Center for Devices and Radiological Health
hair removal
facts
for consumers
Home
