MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO

MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO is an FDA 510(k)-cleared medical device (K081628) 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 June 19, 2008. Regulation: 8.