Soliton, Inc., today announced that its 510(k) application for premarket clearance filed with the U.S. Food and Drug Administration (“FDA”) for its second-generation Rapid Acoustic Pulse (“RAP”) device for cellulite reduction has cleared the agency’s acceptance review. The application now moves to a substantive review. The device is already indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients and this latest new application is for the temporary improvement of the appearance of cellulite. Clinical trials have demonstrated an average 32.5% improvement in the Cellulite Severity Score in our subjects and strong patient satisfaction with 91.9% of subjects agreeing or strongly agreeing that their cellulite appeared improved. Further, there were no unexpected or serious adverse events and the average pain scores were 2.4 on a 10-point scale.
Dr. Christopher Capelli, president and CEO of Soliton, said, “We are very pleased with the progress of our premarket notification through the FDA review process.” Dr. Capelli continued, “Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device.”