Soliton, Inc. filed for 510(k) premarket clearance with the U.S. Food and Drug Administration (FDA) of its second-generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance of cellulite.
The RAP device was previously cleared by the FDA as an accessory to a 1064 nm Q-switched laser for tattoo removal of black ink on patients with skin tones on the Fitzpatrick scale between I and III.
The 510(k) filing is based on results from Soliton's pivotal cellulite clinical trial that were recently presented in an oral presentation via the American Academy of Dermatology (AAD) 2020 VMX Virtual Conference. The RAP device, which uses rapid pulses of acoustic shockwaves, demonstrated an average reduction of 32.5 percent in the Cellulite Severity Score and strong patient satisfaction demonstrated by 91.9 percent of subjects agreeing or strongly agreeing their cellulite appeared improved. There was a 1.16 mean change in the Cellulite Severity Score for all patients with a primary endpoint target of a 1.00 mean changes. The results were generated by a single, 20 to 30-minute, non-invasive treatment that required no anesthesia and caused no unexpected or serious adverse events. The treatment was well tolerated by the trial subjects, with an average pain score of 2.4 out of 10.
"Our 510(k) submission for the reduction in cellulite appearance represents an exciting step forward in Soliton's U.S. commercialization plans for the RAP device," states Christopher Capelli, MD, founder, President and CEO of Soliton, in a news release. "Supported by our positive pivotal cellulite results generated with only one treatment session per patient, the RAP device has the potential to offer patients a non-invasive treatment to reduce the appearance of cellulite. We hope to offer an innovative aesthetic technology to our customers capable of both tattoo removal and cellulite reduction."