CVUE ADVANCED HYDRA VUE

CVUE ADVANCED HYDRA VUE is an FDA 510(k)-cleared medical device (K121652) manufactured by Unilens Corp., USA. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2012. Regulation: 8.