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.
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