
Procept Biorobotics, Corporation
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AquaBeam Robotic System is an FDA 510(k)-cleared medical device (K212835) 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 October 5, 2021. Regulation: 8.