NIDEK MODELS AC-2100 & 2200

NIDEK MODELS AC-2100 & 2200 is an FDA 510(k)-cleared medical device (K913465) manufactured by Nidek, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 1991. Regulation: 8.