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Biolase Technology, Inc.
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WATERLASE C100, MODEL 7100104 is an FDA 510(k)-cleared medical device (K091922) manufactured by Biolase Technology, 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 13, 2009. Regulation: 8.