FDA Awards 510(k) Clearance for Rapid Pulse Device to Remove Cellulite

The device was well-tolerated among patients in clinical trials.

The US Food and Drug Administration (FDA) has awarded 510(k) clearance for a new rapid acoustic pulse (RAP) technology device for the treatment of cellulite.

The approval, awarded to Soliton, is earmarked for short-term improvement in the appearance of cellulite.

How It Works

The device works by leveraging the power of sound to comfortably break apart the fibrous septa bands beneath the skin that causes cellulite to deliver efficacious results in 1, 40-60 minute treatment.

The treatment is designed to safely deliver, rapid, high-pressure acoustic shockwaves at a rate of up to 100 pulses per second through a replaceable treatment cartridge. The negative pressure component of each acoustic pulse is attenuated to enable the therapy to be provided without creating cavitation or heating, which could result in surrounding tissue damage.

Clinical Trials

The approval is based on multiple clinical trials that showed the device produced the desired results with a single, non-invasive treatment with no anesthesia. There were no unexpected or serious adverse events and the device received strong g patient satisfaction ratings and was well-tolerated.

There was an overall 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," said Elizabeth Tanzi, Director at Capital Laser & Skin Care, and a member of Soliton's Scientific Advisory Board, in a statement. "This non-invasive technology gives us a new cellulite reduction option to help address this unmet need for our patients."

Soliton has indicated plans for the device to enter the market during the first half of 2021.