LOTUS II PULSED ER: YAG LASER SYSTEM

LOTUS II PULSED ER: YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K083253) 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 May 14, 2009. Regulation: 8.