510(k) K183189

Ultra OTC Facial Toning System by Micro Current Technology, Inc. — Product Code NFO

K183189 is an FDA 510(k) premarket notification submitted by Micro Current Technology, Inc. for the device "Ultra OTC Facial Toning System". The FDA issued a decision of Substantially Equivalent on April 17, 2019. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Micro Current Technology, Inc. has at least 7 other 510(k) clearances on record.