Cleared Traditional

K181008 - NuFACE Trinity

K181008 is an FDA 510(k) clearance for NuFACE Trinity, 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 177-day FDA review.

K181008 · Carol Cole Company Dba Nuface · Neurology device
Download Printable Device Report (PDF)
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Oct 2018
Decision
177d
Days
Class 2
Risk

K181008 is an FDA 510(k) clearance for the NuFACE Trinity. 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 11, 2018 after a review of 177 days - an extended review cycle.

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 - K181008

510(k) Number K181008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date October 11, 2018
Days to Decision 177 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
29d slower than avg
Panel avg: 148d · This submission: 177d
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 K181008.
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
Ultra Facial Toning System
K181062 · Micro Current Technology, Inc. · Jul 2018
TAMA BEMS device
K173093 · Tama Research Corporation · Jun 2018
2 Face / Face Evolution
K171821 · Heat IN A Click · Apr 2018