
Aesculap-Meditec North America
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DERMABLATE ER: YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K980361) manufactured by Aesculap-Meditec North America. 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 April 20, 1998. Regulation: 8.