NIDEK MODEL GYC-1500 AND GYC-2000

NIDEK MODEL GYC-1500 AND GYC-2000 is an FDA 510(k)-cleared medical device (K951079) manufactured by Nidek, 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 September 13, 1995. Regulation: 8.