LENSAR Laser System - fs 3D (LLS-fs 3D)

LENSAR Laser System - fs 3D (LLS-fs 3D) is an FDA 510(k)-cleared medical device (K182795) 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 December 20, 2018. Regulation: 8.