PAFLUFOCON A, B, C & D

PAFLUFOCON A, B, C & D is an FDA 510(k)-cleared medical device (K940277) 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 May 8, 1994. Regulation: 8.