LENSAR Laser System - fs 3D

LENSAR Laser System - fs 3D is an FDA 510(k)-cleared medical device (K143010) manufactured by Lensar, 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 March 19, 2015. Regulation: 8.