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Bausch & Lomb
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BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS is an FDA 510(k)-cleared medical device (K020927) manufactured by Bausch & Lomb. 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 15, 2002. Regulation: 8.