MAINSTER HIGH MAGNIFICATION LASER LENS

MAINSTER HIGH MAGNIFICATION LASER LENS is an FDA 510(k)-cleared medical device (K912366) manufactured by Ocular Instruments, 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 June 24, 1991. Regulation: 8.