EnFocus 2300, EnFocus 4400

EnFocus 2300, EnFocus 4400 is an FDA 510(k)-cleared medical device (K150722) manufactured by Bioptigen, 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 December 1, 2015. Regulation: 8.