Apyx Medical submits FDA 510k to U.S. FDA for label expansion of AYON

Apyx Medical (APYX) announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration, FDA, for the label expansion of the AYON Body Contouring System, AYON, to include power liposuction. Receiving market clearance for power liposuction would solidify AYON’s position as the first fully integrated body contouring system. As a result, surgeons would be able to address every aspect of contouring within one platform, streamlining workflow, and potentially enhancing outcomes, and positioning AYON as the new gold standard in surgical aesthetics.