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Biolitec, Inc.
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CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 is an FDA 510(k)-cleared medical device (K081015) 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 July 7, 2008. Regulation: 8.