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Biolitec, Inc.
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MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS is an FDA 510(k)-cleared medical device (K010804) manufactured by Biolitec, 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 October 3, 2001. Regulation: 8.