Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.”
“We are pleased to receive 510(k) clearance for the use of the Renuvion APR Handpiece for coagulation of subcutaneous soft tissues specifically following liposuction for aesthetic body contouring. The Renuvion APR handpiece is the only device to have a 510(k) clearance for use following liposuction” said Charlie Goodwin, President and Chief Executive Officer of Apyx Medical. “This 510(k) clearance further demonstrates the safety and effectiveness of our Renuvion technology, and our continued commitment to working with the FDA to secure specific clinical indications.”
Mr. Goodwin continued: “We are proud of the strong progress made by our regulatory and clinical teams to secure clearances supporting the safe and effective use of our Advanced Energy products. Specifically, in the last twelve months we have received four 510(k) clearances for the use of our Renuvion handpieces in specific clinical indications, all of which are supported by substantial evidence demonstrating the safety of our products. Importantly, we believe we now have the requisite 510(k) clearances to resolve the remaining limitations of the FDA Safety Communication. We look forward to empowering surgeons and physicians to obtain the clinical results they, and their patients, are seeking by expanding the adoption and utilization of our Renuvion technology for these specific clinical indications. Moreover, with large and rapidly growing addressable markets that we are just beginning to penetrate, and a dedicated team of employees, we remain excited about our future prospects in the years to come.”