WAVELIGHT FS200 LASER SYSTEM MODEL: FS200

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 is an FDA 510(k)-cleared medical device (K101006) manufactured by Alcon Research, 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 October 20, 2010. Regulation: 8.