COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS

COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS is an FDA 510(k)-cleared medical device (K014035) manufactured by Cooltouch Corp.. 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 March 6, 2002. Regulation: 8.