COOLTOUCH VARIA-II ND:YAG LASER SYSTEM

COOLTOUCH VARIA-II ND:YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K003781) 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 December 19, 2000. Regulation: 8.