Aerin Medical Wand Model FG011

Aerin Medical Wand Model FG011 is an FDA 510(k)-cleared medical device (K150637) manufactured by Aerin Medical, 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 November 18, 2015. Regulation: 8.