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Opti-Centre Laboratories
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PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) is an FDA 510(k)-cleared medical device (K043129) manufactured by Opti-Centre Laboratories. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 2005. Regulation: 8.
