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Innovaquartz
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SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS is an FDA 510(k)-cleared medical device (K050108) manufactured by Innovaquartz. 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 March 13, 2005. Regulation: 8.