COOLIEF Cooled Radiofrequency Kit Advanced

COOLIEF Cooled Radiofrequency Kit Advanced is an FDA 510(k)-cleared medical device (K203066) manufactured by Avanos Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2020. Regulation: 8.