OPHALMIC LASER PHOTOCOAGULATOR

OPHALMIC LASER PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K854288) manufactured by Mira, 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 November 11, 1985. Regulation: 8.