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Lightscalpel, LLC
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LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS is an FDA 510(k)-cleared medical device (K121471) manufactured by Lightscalpel, 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 July 9, 2012. Regulation: 8.