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Bausch & Lomb, Inc.
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PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS is an FDA 510(k)-cleared medical device (K050948) manufactured by Bausch & Lomb, 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 May 17, 2005. Regulation: 8.