GEMINI SURGICAL LASER SYSTEM & ACCESSORIES

GEMINI SURGICAL LASER SYSTEM & ACCESSORIES is an FDA 510(k)-cleared medical device (K034011) manufactured by Laserscope. 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 29, 2004. Regulation: 8.