Soliton (NASDAQ:SOLY) filed for 510(k) premarket clearance with the FDA of its second generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance of cellulite.
The 510(k) filing is based on results from Soliton’s pivotal cellulite clinical trial. The RAP device demonstrated an average reduction of 32.5% in the cellulite severity score, with 91.9% of subjects agreeing or strongly agreeing their cellulite appeared improved.
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.
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.
“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,” Dr. Christopher Capelli, founder, president and CEO, said in a statement.
“We hope to offer an innovative aesthetic technology to our customers capable of both tattoo removal and cellulite reduction,” he added.