COOLTOUCH MODELS LC215 AND COOLLIPO

COOLTOUCH MODELS LC215 AND COOLLIPO is an FDA 510(k)-cleared medical device (K080163) 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 April 9, 2008. Regulation: 8.