Cleared Traditional

NuFace Trinity Plus Device (K201782) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201782 · Carol Cole Company Dba Nuface · Neurology device
Download Printable Device Report (PDF)
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Jan 2021
Decision
206d
Days
Class 2
Risk

K201782 is an FDA 510(k) clearance for the NuFace Trinity Plus 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 January 22, 2021 after a review of 206 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

Submission Details

510(k) Number K201782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2020
Decision Date January 22, 2021
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Bob Duffy Associates, Inc.
Bob Duffy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 50
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K201782.
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
K191951 · Avazzia, Inc. · Apr 2021
Trinity ELE Plus and Trinity ELE Plus Pro
K201906 · Carol Cole Company Dba Nuface · Feb 2021
NuFACE Mini Plus
K201680 · Carole Cole Company · Feb 2021
Tua Face Fitness / Tua Trend Face
K192077 · Vupiesse S.R.L · Sep 2020
BEAR and BEAR mini
K200803 · Foreo, Inc. · Jul 2020
NuFACE Mini Device
K191672 · Carol Cole Company Dba Nuface · Oct 2019