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Carl Zeiss Meditec, AG
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VISULAS TRION LASER SYSTEM WITH THE VITE OPTION is an FDA 510(k)-cleared medical device (K103056) manufactured by Carl Zeiss Meditec, AG. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2011. Regulation: 8.