DERMATOLOGY HANDPIECE-OPHTH LASER

DERMATOLOGY HANDPIECE-OPHTH LASER is an FDA 510(k)-cleared medical device (K833274) manufactured by Synemed, 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 2, 1983. Regulation: 8.