APEX 800 LASER SYSTEM, MODEL APEX 800

APEX 800 LASER SYSTEM, MODEL APEX 800 is an FDA 510(k)-cleared medical device (K020849) manufactured by Iridex 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 May 19, 2002. Regulation: 8.