NIDEK MODEL VT-4000, MODIFICATION

NIDEK MODEL VT-4000, MODIFICATION is an FDA 510(k)-cleared medical device (K936302) 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 July 14, 1994. Regulation: 8.