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Ace Vision Group
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VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K070296) manufactured by Ace Vision Group. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2007. Regulation: 8.