FDA Accepts Special 510(k) Application for Modifications to Soliton's Resonic

The FDA has accepted a special 510(k) application for modifications to Soliton's Resonic Rapid Acoustic Pulse (RAP) technology prior to commerical launch. Decisions usually take 15 to 20 days. Soliton submitted the application on March 31 and announced it was received on April 15.

The changes submitted in the special 510(k) application include the development of an autoloading cartridge and an improved user interface. Soliton says these modifications are geared towards providing for a more seamless user experience.

In anticipation of commercial launch in Q2 2021, the Company expanded its sales team through the hiring of two Senior Practice Development Managers with previous experience in the aesthetics space. They will focus on in-practice execution of the introduction and support of the Resonic device and RAP technology.