AOCup Lens Case with AODisc

AOCup Lens Case with AODisc is an FDA 510(k)-cleared medical device (K191795) manufactured by 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 July 30, 2019. Regulation: 8.