
Asclepion Laser Technologies GmbH
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MCL 30 DERMABLATE ER:YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K042968) manufactured by Asclepion Laser Technologies GmbH. 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 November 23, 2004. Regulation: 8.