While conducting our research on Lipo Ex (more info here) we tried to figure out whether this system has got FDA Approval. Actually the online information about it was conflicting while some sources mentioned that it received FDA Approval on January 2012 and other were insisting that Lipo Ex didn’t receive FDA Approval. What’s the truth?
Lipo EX’s manufacturers attempted to gain FDA approval on 2010 but their request was rejected! Then they asked FDA to approve LipoTron as a massager (while its not necessary to get FDA approval to sell a massager). The thing is that doctors and aesthetic institutions promote Lipo Ex as a fat removal device (and not as a massager) which is illegal! Several doctors claim that its FDA Approval was imminent and this is why we contacted FDA in order to find the real truth! Here is their answer:
Your interest in contacting the US Food and Drug Administration (FDA) through your recent email is appreciated.
My research into the FDA medical device databases does not show any clearance documents for the Lipo Ex. I checked into the premarket notification 510(k) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm to no avail, typing the name of the device into the Device Name blank. I also searched the Registration and Listing database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm, also with no results for such a device.
Hopefully, this response will be of assistance. You are wished the best in your website endeavor and also in the management of your own health care!
Public Health Advisor
Communication and Education Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration