
Ocu-Ease Optical Products, Inc.
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OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K003996) 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 February 20, 2001. Regulation: 8.