MODEL 1000 HOLMIUM LASER SYSTEM

MODEL 1000 HOLMIUM LASER SYSTEM is an FDA 510(k)-cleared medical device (K994273) 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 January 19, 2000. Regulation: 8.