IRIDIS OPHTHALMIC PHOTOCOAGULATOR

IRIDIS OPHTHALMIC PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K023094) manufactured by Quantel Medical. 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 16, 2002. Regulation: 8.