Apyx Medical announces FDA 510k submission for Renuvion use post liposuction

Apyx Medical announced it has submitted a 510 k premarket notification, 510 k submission, for the Renuvion APR Handpiece to the U.S. Food and Drug Administration, FDA , supported by a clinical study and real-world evidence. The 510 k submission is intended to expand Renuvion’s indications for use to include a specific indication for the use of the Renuvion APR Handpiece for the coagulation of subcutaneous soft tissues where needed, following liposuction. "We are pleased to announce the submission of this request for 510 k clearance for a new clinical indication, which is intended to enable Apyx Medical to market and sell our Renuvion APR Handpiece for use following liposuction," said Charlie Goodwin, President and Chief Executive Officer. "This 510 k submission leverages the substantial history of safe use of the Renuvion APR handpiece following liposuction procedures, and as such, Apyx Medical was able to assess the device based on a large set of retrospective chart reviews. Importantly, our analysis of Renuvion treatment adverse events, when compared to the real-world evidence gathered for liposuction treatments in the literature review, demonstrated that there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone."