
Plasma Concepts
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Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is an FDA 510(k)-cleared medical device (K223440) manufactured by Plasma Concepts. 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 March 1, 2023. Regulation: 8.