IHRS cited for violations by FDA

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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