Puddles, sorry to hear you were a victim of these guys. You'll need to file a complaint with the Better Business Bureau. If that doesn't work, you'll need to file a small claims suit.
Here's a summary of the matter:http://www.hairfacts.com/makers/etweezer/ihrs/fdaviolations.html
You should send BBB a copy of this letter:http://www.hairfacts.com/makers/etweezer/ihrs/fda1001.html
"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."
They will try to claim that it's your fault. Don't let the issue waver from the fact that claiming the device is permanent is a violation of federal regulations and that there is no published proof it is permanent.
You will need the following:
1. Receipts of payment. Dates of treatment.
2. Promotional literature claiming the patch used on you is permanent. Web printouts, magazine and newspaper ads, brochures, etc. Be sure you have some from the practitioner who treated you.
3. Do not remove any hair in the treated area between now and your court date if possible.
They will try to weasel out of paying it all back. Hold them to a complete settlement. If they start claiming they will fight this in court, they're just trying to scare you. They know you have them dead to rights on this.
They will try to baffle the BBB and the small claims mediator with BS and throw out all kinds of irrelevant stuff. They might even try to disparage me and say all sorts of things about me and my website.
They will claim they have clearance for another device (the TE 629 electric tweezer). The FDA letter says this is irrelevant and that their claims about the patch are illegal.
They may try to pull out a report written my Dr. Mark Chandler and/or Dr. Paul DesRuisseaux. Both these men sell the devices and have designed a report that is supposed to confuse court mediators. The shoddy report is not published and has no follow-up results. They followed the subjects for zero days after the final treatment. FDA requires significant follow-up to allow a claim of permanent hair removal. They may claim that this report has been submitted to FDA, but FDA has not evaluated any formal submission from Rejuvenu and has not cleared the transcutaneous patch for any indication, let alone permanent hair removal.
The simple fact is this. They say their transcutaneous patch is permanent. FDA says this claim is illegal. And you have the actual letter from FDA.
Keep emphasizing to the mediator that these people have faced many similar lawsuits and are very adept at clouding the issue with irrelevant information. Their product is in violation of federal regulations, and you have been misled by their promotional materials. You deserve a full refund and a little extra for your time and trouble.
Please contact me if you have any questions, and I will be happy to elaborate. The only thing I ask in return is that you take notes during the procedure and let me know how they try to get out of paying you. This will let me help others better, since these people are constantly retooling their lawsuit strategy.