FDA regulatory letters to Rejuvenu
Throughout the 1990’s and into the new century, International Hair Removal Systems (IHRS) has been making claims that their SuperPhaser Gold, Pinnacle 1250, TransQ-2000 and TD-829 devices can cause permanent hair removal and are FDA approved. This is untrue and in violation of federal regulations. Rejuvenu was claiming they had clearance based on a 1990 decision by FDA regarding an electric tweezer (for details, click here).
In 1995, IHRS attempted to get FDA clearance for the transcutaneous patch (Docket K955584), under the name AHRS Surface Electrolysis System. This submission indicated that IHRS/Rejuvenu understood they needed a new clearance for this modification to their equipment. It was never cleared.
On 20 July 1999, FDA Consumer Safety Officer Patricia Jahnes sent a letter to IHRS medical director Mark H. Chandler regarding these violations and never received a response.
Since this letter went out, IHRS changed their name to Rejuvenu.
On 02 April 2001, FDA Consumer Safety Officer Patricia Jahnes sent a letter to IHRS CEO Lee Cole, stating:
"According to our Office of Device Evaluation (ODE), the patch epilator has not been cleared by FDA for any indication.
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 never received a response."
On 23 May 2001 Lee Cole of Rejuvenu responded:
"IHRS claim that the Super-Phaser Gold permanently removes hair does not change the intended use of the device, so the Super-Phaser Gold is not adulterated or misbranded."
"merely a modified tweezer-type epilator that still has the same intended use."
FDA didn’t buy it. On 17 October 2001, FDA responded:
"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."
There are no premarket notification clearances, for any indication, for so-called hands-free transcutaneous, transdermal cotton-tipped applicator probes, or continuous hair removal."
No doubt Mr. Cole will continue to promote his Rejuvenu device in violation of federal regulations. I will be doing what I can to get Rejuvenu slapped with fines for defrauding consumers like this.
If you have been a victim of transcutaneous or transdermal manufacturers or practitioners (Rejuvenu or anyone else), I can help you reclaim your money in small claims court. I have assisted consumers in reclaiming thousands of dollars from Rejuvenu practitioners. Please contact me for details.
If you see an ad claiming permanent hair removal with a transcutaneous device, please contact me.