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Biolitec Medical Devices, Inc.
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CERALAS 980NM DIODE LASER FAMILY is an FDA 510(k)-cleared medical device (K112324) manufactured by Biolitec Medical Devices, 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 September 5, 2011. Regulation: 8.