OPTIMEDICA CATALYS PRECISION LASER SYSTEM

OPTIMEDICA CATALYS PRECISION LASER SYSTEM is an FDA 510(k)-cleared medical device (K141079) manufactured by Optimedica Corporation. 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 10, 2014. Regulation: 8.