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A.R.C. Laser AG
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LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II is an FDA 510(k)-cleared medical device (K003512) manufactured by A.R.C. Laser 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 February 7, 2001. Regulation: 8.