FDA Clears Soliton’s RAP Device for Cellulite

Medical device company Soliton announced the FDA clearance of its Rapid Acoustic Pulse (RAP) device for the short-term improvement in appearance of cellulite, according to a company press release.¹

Soliton’s RAP device utilizes a rapid pulse of acoustics to break apart the fibrous septa band underneath the skin that causes cellulite. The device provides efficient results in one 40–60-minute treatment.

"We’re thrilled to receive this latest clearance for our RAP technology,” said Brad Hauser, president and 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.”

In clinical studies, the RAP device received strong patient satisfaction ratings, and was shown to be well-tolerated by patients, with no reported unexpected or serious adverse events.

“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,” said Elizabeth Tanzi, director at Capital Laser & Skin Care, Chevy Chase, MD and a member of Soliton’s Scientific Advisory Board. “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. This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients.”

Most recently in March 2020², the company received FDA 510(k) clearance on its RAP device for tattoo removal.

Soliton plans to sell the device for both cellulite and tattoo removal beginning in the first half of 2021, according to a press release.

References:

1. Soliton announces fda clearance of rapid acoustic pulse technology for use in cellulite. BioSpace. Accessed February 1, 2021. https://www.biospace.com/article/soliton-announces-fda-clearance-of-rapid-acoustic-pulse-technology-for-use-in-cellulite/

2. Soliton’s Generation II tattoo-removal device receives 510(K) premarket notification. Dermatology Times. Accessed February 1, 2021. https://www.dermatologytimes.com/view/solitons-tattoo-removal-device-receives-510k-premarket-notification