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Soflex Contact Lens Industries , Ltd.
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ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP is an FDA 510(k)-cleared medical device (K030842) manufactured by Soflex Contact Lens Industries , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 2003. Regulation: 8.
