PMW01 Procedure Mask Level 1

PMW01 Procedure Mask Level 1 is an FDA 510(k)-cleared medical device (K211772) manufactured by Defender Safety, Inc.. 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 December 5, 2021. Regulation: 8.