
Apyx Medical Corporation
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AYON Body Contouring System (AYON SYSTEM) is an FDA 510(k)-cleared medical device (K253396) manufactured by Apyx Medical Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 2026. Regulation: 8.