PVS BASIC 2; EPIC 2

PVS BASIC 2; EPIC 2 is an FDA 510(k)-cleared medical device (K013310) manufactured by Paragon Vision Sciences. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2002. Regulation: 8.