Catalys™ Precision Laser System

Catalys™ Precision Laser System is an FDA 510(k)-cleared medical device (K223838) manufactured by Amo Manufacturing USA, LLC. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2023. Regulation: 8.