FDA regulatory letter to International Hair Removal Systems Below is the text and scan of the FDA letter sent to  International Hair Removal
Systems (IHRS). The company changed their name to Rejuvenu
International Limited soon after.
For years, IHRS has been making claims that their SuperPhaser
Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause
permanent hair removal. This claim about Super Phaser Gold is
untrue and in violation of federal regulations.
Click here for background.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850
APR -2 2001
VIA FACSIMILE
H. Lee Cole
Chief Executive Officer
International Hair Removal Systems, Inc.
230 North Bennet Street
Suite 101
Southern Pines, North Carolina 28387
Re: Hair Removal Devices
Dear Mr. Cole:
The Food and Drug Administration (FDA) has reviewed promotional
materials and your website at http://www.ihrsinc.com for the Super-Phaser
Gold and Transcutaneous Electro Patch System. These products are
devices as defined within the meaning of section 201(h) of the
Federal Food, Drug, and Cosmetic Act (the Act).
The March 2001 issue of Skin Inc. contains an advertisement
for International Hair Removal Systems' Transcutaneous Electro
Patch System, which includes the claims "Permanent HAIR REMOVAL...permanent
painless non-invasive....NO pain...NO MORE HAIR!" Additional
claims include "NO bruising, NO scabbing, NO scarring."
The issue also included a "Supplier Spotlight" article
on International Hair Removal System, Inc., which was noted to
be written by Ed Wait, Director of Sales for your firm. The article
discusses the Super-Phaser Gold System, and patch transcutaneous
electrolysis and how it works, including claims that there is
no invasion of the skin and no pain, and a training program at
your firm includes everything needed to be successful in the permanent
hair removal business using the system.
Your website's home page indicates "TRANSCUTANEOUS ELECTRO
PATCH SYSTEM....Permanent HAIR removal." The various website
links and sublinks take the reader to discussions on the Super-Phaser
Gold and the Transcutaneous Patch, with claims that the Super-Phaser
is a FDA Class I medical device indicated for permanent removal
of unwanted facial and body hair, with 4 different methods of
treatment: hands-free transcutaneous, continuous, transdermal,
and tweezer, that the Super-Phaser Gold is the first hair removal
product that can permanently disable large numbers of hair follicles
without the use of needles via a technological breakthrough called
Transcutaneous Electrolysis, the Super-Phaser Gold treatment is
the fastest and most effective permanent treatment on the market
today; and the treatment is painless, and that permanence is equal
to needle electrolysis. Additional claims include that there is
no risk of infection, pitting, or changes of pigmentation. There
are several statements on the web site that indicate that FDA
clearances have been obtained or that the device is FDA approved.
Epilators are devices that are intended to remove hair. At the
present time, both needle and tweezer type epilators are exempt
from the 510(k) premarket notification process. However, there
are no premarket notification clearances for so-called hands-free
transcutaneous, transdermal, or continuous hair removal. Your
device is not exempt from the 510(k) requirement because it constitutes
a fundamental change in scientific technology. According
to our Office of Device Evaluation (ODE), the patch epilator has
not been cleared by FDA for any indication. Your
firm continues to use an original clearance for a standard epilator
to "cover" the clearance for the patch system. You submitted
a 510(k) for this device in 1995 (K955584), but ODE sent a "Cannot
Respond" letter to you, and your firm never responded. Subsequently,
you started marketing the device and have been doing so ever since,
along with claims that it has been FDA approved. Appropriate data
have not been submitted to support claims of no risk of infection,
pitting, changes of pigmentation, no bruising, no scabbing, or
no scarring, or that the procedure is painless. Please provide
evidence to support these claims.
Page 2 - Lee Cole, Chief Executive Officer
Practitioners making claims of permanent hair removal for epilators
change the intended uses of the device as described under 21 CFR
807.8l(a)(3)(ii) and make them subject to the premarket notification
requirements. Continued promotion of the Super-Phaser
Gold System and Transcutaneous Patch for claims of permanent hair
removal misbrands and adulterates your device within
the meaning of sections 502(o) and 501(f)(1)(B) of the Act, respectively.
We wish to note that these issues
have been previously addressed by us. We sent
a letter to Dr. Mark Chandler, dated July 20, 1999, concerning
promotional claims being made for a device called the TD-829 Hair
Removal Machine. This product appears to be the same device as
the Super-Phaser Gold, using the same 4 methods of treatment:
hands-free, continuous, transdermal, and tweezer. The same basic
claims, for no pain and permanent hair removal, were also being
made for this device. We never received
a response, although a green return receipt card,
which appears to have your signature, was received by us.
Please respond promptly to this letter, outlining the steps you
have taken to correct the cited violations. Your response should
also include all steps being taken to address misleading information
currently in the marketplace and actions to prevent similar violations
in the future. Your response should be sent to me at the letterhead
address.
Sincerely yours,
[signed]
Patricia L. Jahnes
Consumer Safety Officer
Promotion and Advertising Policy Staff
Office of Compliance
Center for Devices and Radiological Health
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