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Sandstone Medical Technologies, LLC
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LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) is an FDA 510(k)-cleared medical device (K040563) manufactured by Sandstone Medical Technologies, LLC. 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 7, 2004. Regulation: 8.