NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000

NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000 is an FDA 510(k)-cleared medical device (K901686) 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 June 7, 1990. Regulation: 8.