DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES is an FDA 510(k)-cleared medical device (K072789) manufactured by Encision, 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 October 18, 2007. Regulation: 8.