LenSx Laser System (8065998162)

LenSx Laser System (8065998162) is an FDA 510(k)-cleared medical device (K243896) 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 April 27, 2025. Regulation: 8.