
Ocular Sciences Puerto Rico, Inc.
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BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K013377) manufactured by Ocular Sciences Puerto Rico, 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 19, 2001. Regulation: 8.