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New Star Lasers, Inc.
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COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS is an FDA 510(k)-cleared medical device (K031954) manufactured by New Star Lasers, 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 August 20, 2003. Regulation: 8.