OCU-FLEX-38 (POLYMACON)

OCU-FLEX-38 (POLYMACON) is an FDA 510(k)-cleared medical device (K941998) manufactured by Ocu-Ease Optical Products, 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 October 12, 1994. Regulation: 8.