WAVELIGHT FS200 LASER SYSTEM

WAVELIGHT FS200 LASER SYSTEM is an FDA 510(k)-cleared medical device (K141476) manufactured by Alcon Research, Ltd. Dba Alcon Laboratories, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2014. Regulation: 8.