CANDELA UPC LASER PHOTOCOAGULATOR

CANDELA UPC LASER PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K893630) manufactured by Candela Laser Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 1989. Regulation: 8.