
Sandstone Medical Technologies, LLC
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TRIPLEX ER. YAG / ND: YAG SYSTEM is an FDA 510(k)-cleared medical device (K110502) 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 April 26, 2011. Regulation: 8.