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Volk Optical, Inc.
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VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D is an FDA 510(k)-cleared medical device (K050623) manufactured by Volk Optical, 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 March 27, 2005. Regulation: 8.