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Essilor Intl.
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VARILUX VISIONPRINT SYSTEM (VPS) is an FDA 510(k)-cleared medical device (K033949) manufactured by Essilor Intl.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2004. Regulation: 8.