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Biolitec, Inc.
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15W CERALAS D 1470NM DIODE LASER, MODEL D1470 is an FDA 510(k)-cleared medical device (K082225) 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 December 2, 2008. Regulation: 8.