Cleared Traditional

K161654 - NuFACE Gel Primer

K161654 is an FDA 510(k) clearance for NuFACE Gel Primer, manufactured by Carol Cole Company. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K161654 · Carol Cole Company · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
198d
Days
Class 2
Risk

K161654 is an FDA 510(k) clearance for the NuFACE Gel Primer. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Carol Cole Company (Vista, US). The FDA issued a Cleared decision on December 30, 2016 after a review of 198 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 devices

FDA 510(k) Submission Details - K161654

510(k) Number K161654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2016
Decision Date December 30, 2016
Days to Decision 198 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 148d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 31
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K161654.
Elefix V Paste for EEG & EMG
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SAC2 - Electrode Cream
K192606 · Spes Medica Srl · Jan 2020
Tech Dots - Adhesive and conductive gel
K190050 · Spes Medica Srl · Jul 2019
BATCH #6060 CONDUCTIVE GEL
K983964 · Skylark Device Co., Ltd. · Dec 1998
MODEL 1700, HYDRO PREP
K970694 · Physiometrix, Inc. · May 1997
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996