Soliton Receives FDA Clearance of Special 510(k)

Saturday, May 01, 2021

Soliton, Inc., a medical device company with a novel and proprietary platform technology, today announced the U.S. Food and Drug Administration ("FDA") clearance of the Company's special 510(k) for modifications to its RESONIC™ device.

"We were thrilled to receive this clearance as it marks the last significant hurdle to our ability to initiate our commercial launch of the improved RESONIC device in the second quarter," stated Brad Hauser, Soliton CEO and President. "Our discussions with our target dermatologists and plastic surgeons on our Rapid Acoustic Pulse (RAP) technology have been very well received and there is strong enthusiasm for an effective and efficient patient experience for tattoo removal and cellulite treatment with the RESONIC device over the coming months."

The RESONIC device utilizes the RAP technology to deliver safe and effective tattoo removal and cellulite treatment and now includes an autoloading cartridge and an improved user interface. These modifications are geared towards providing for a more seamless user experience. The special 510(k) application was submitted to the FDA on March 31, 2021.

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