510(k) K150453

TULA Iontophoresis System with Earset by Acclarent, Inc. — Product Code EGJ

K150453 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "TULA Iontophoresis System with Earset". The FDA issued a decision of Substantially Equivalent on May 20, 2015. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Acclarent, Inc. has at least 10 other 510(k) clearances on record.