
Bovie Medical Corporation Dba Apyx Medical Corporation
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Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) is an FDA 510(k)-cleared medical device (K192867) manufactured by Bovie Medical Corporation Dba 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 October 30, 2019. Regulation: 8.