Cleared Traditional

K191672 - NuFACE Mini Device

K191672 is an FDA 510(k) clearance for NuFACE Mini Device, manufactured by Carol Cole Company Dba Nuface. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K191672 · Carol Cole Company Dba Nuface · Neurology device
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Oct 2019
Decision
113d
Days
Class 2
Risk

K191672 is an FDA 510(k) clearance for the NuFACE Mini Device. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Carol Cole Company Dba Nuface (Vista, US). The FDA issued a Cleared decision on October 15, 2019 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carol Cole Company Dba Nuface devices

FDA 510(k) Submission Details - K191672

510(k) Number K191672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2019
Decision Date October 15, 2019
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
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 Neurology 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 K191672.
NuFace Trinity Plus Device
K201782 · Carol Cole Company Dba Nuface · Jan 2021
Tua Face Fitness / Tua Trend Face
K192077 · Vupiesse S.R.L · Sep 2020
BEAR and BEAR mini
K200803 · Foreo, Inc. · Jul 2020
PureLift
K190269 · Xtreem Pulse, LLC · Aug 2019
Ultra OTC Facial Toning System
K183189 · Micro Current Technology, Inc. · Apr 2019
NuFACE FIX Skin Toning Device
K182424 · Carol Cole Company Dba Nuface · Dec 2018