TULA Iontophoresis System with Earset

TULA Iontophoresis System with Earset is an FDA 510(k)-cleared medical device (K150453) manufactured by Acclarent, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2015. Regulation: 8.