HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM

HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K083203) manufactured by Laseroptek Co., Ltd.. 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 April 27, 2009. Regulation: 8.