
Incisive, Inc. (Formerly Named Incisive, LLC)
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PINPOINTE FOOTLASER MODEL 6W, 30W, 100W is an FDA 510(k)-cleared medical device (K093545) manufactured by Incisive, Inc. (Formerly Named Incisive, 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 14, 2010. Regulation: 8.