
Biolitec, Inc.
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CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 is an FDA 510(k)-cleared medical device (K082263) 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 23, 2008. Regulation: 8.