FDA Nod for Modifications to Soliton's Resonic Device

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.

The U.S. Food and Drug Administration granted Soliton, Inc. 510(k) for modifications to its RESONIC device.

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

"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,"says Brad Hauser, Soliton CEO and President, in a news release. "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 special 510(k) application was submitted to the FDA on March 31, 2021.