Pulsaderm ACE-All Blue

Pulsaderm ACE-All Blue is an FDA 510(k)-cleared medical device (K162371) manufactured by Nutra Luxe MD, 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 December 14, 2016. Regulation: 8.