ION MEDICAL BIPOLAR COAGULATION PEN

ION MEDICAL BIPOLAR COAGULATION PEN is an FDA 510(k)-cleared medical device (K072911) manufactured by Ion Medical, 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 12, 2007. Regulation: 8.