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Procept Biorobotics, Corporation
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AQUABEAM System is an FDA 510(k)-cleared medical device (DEN170024) manufactured by Procept Biorobotics, Corporation. 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 December 20, 2017. Regulation: 8.