Rejuvenu cited for violations by FDA

FDA regulatory letter to Rejuvenu

Below is a scan of the FDA letter sent to Rejuvenu International Limited (formerly International Hair Removal Systems (IHRS).

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.

Click here for background on Rejuvenu and their dealings with FDA.

 

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

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