
R2 Dermatology ,Inc
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Dermal Cooling System is an FDA 510(k)-cleared medical device (K171398) manufactured by R2 Dermatology ,Inc. 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 5, 2017. Regulation: 8.