Solta Warning Letter Recounts Problems With Three Laser Trials

A warning letter to Solta Medical recently posted to the FDA’s website reveals concerns that the devicemaker put patients at risk during three clinical trials. The letter recounts four violations related to trials for the ISIS Laser, Serenity Skin Rejuvenation System and Janus Resurfacing Laser and follows a July 12 to Aug. 17, 2012, inspection of trial records by the San Francisco district office. None of the products appear to have been approved for U.S. use, and Solta spokeswoman Amy Phillips said the trials discussed took place more than four years ago.
Devices & Diagnostics Letter