
Ocu-Ease Optical Products, Inc.
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OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) is an FDA 510(k)-cleared medical device (K023077) 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 December 9, 2002. Regulation: 8.