The FDA has cleared Soliton Inc.’s Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite. Harnessing the power of sound, the unique, rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver results in one, 40–60-minute treatment. 

In clinical trials submitted to the FDA as part of the 510(k) application, results were seen with a single, non-invasive treatment that required no anesthesia and caused no unexpected or serious adverse events. Patients reported strong satisfaction ratings. Treatment was well tolerated, with an average pain score of 2.4 out of 10. 

"Until now, patients have had limited options to effectively improve the appearance of cellulite other than cutting into the skin or less invasive procedures that can have low patient satisfaction. The clearance of this technology for cellulite fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients effective procedures without any downtime," says Elizabeth Tanzi, Director at Capital Laser & Skin Care, Chevy Chase, MD and a member of Soliton's Scientific Advisory Board. "This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients."

Soliton's RAP technology received 510(k) clearance from the FDA for the removal of tattoos in mid-2019 and plans to begin selling the device for both tattoo removal and cellulite treatment in the first half of 2021.

"We're thrilled to receive this latest clearance for our RAP technology," says Brad Hauser, President & CEO of Soliton. "Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come."  

Editor’s note: Soliton Co-Founder and Executive Chairman Wally Klemp spoke about RAP technology with host Joel L. Cohen, MD for an episode of Scientifically Speaking. Watch now to learn more.