Cleared Traditional

K183189 - Ultra OTC Facial Toning System

K183189 is an FDA 510(k) clearance for Ultra OTC Facial Toning System, manufactured by Micro Current Technology, Inc.. The device is a Class 2 Physical Medicine device with product code NFO cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K183189 · Micro Current Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
149d
Days
Class 2
Risk

K183189 is an FDA 510(k) clearance for the Ultra OTC Facial Toning System. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Micro Current Technology, Inc. (Seattle, US). The FDA issued a Cleared decision on April 17, 2019 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Current Technology, Inc. devices

FDA 510(k) Submission Details - K183189

510(k) Number K183189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date April 17, 2019
Days to Decision 149 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K183189.
BEAR and BEAR mini
K200803 · Foreo, Inc. · Jul 2020
NuFACE Mini Device
K191672 · Carol Cole Company Dba Nuface · Oct 2019
PureLift
K190269 · Xtreem Pulse, LLC · Aug 2019
NuFACE FIX Skin Toning Device
K182424 · Carol Cole Company Dba Nuface · Dec 2018
NuFACE Trinity
K181008 · Carol Cole Company Dba Nuface · Oct 2018
Ultra Facial Toning System
K181062 · Micro Current Technology, Inc. · Jul 2018