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Carol Cole Company Dba Nuface

8 FDA records filed under this company name, from 2017 to 2024, in microcurrent and ems (NFO, 7), light for wrinkles (OHS, 1).

Also filed with slightly different spelling: “Carol Cole Company Dba Nuface®”. We group names that differ only in capitals, spacing or punctuation.

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 7)

510(k) clearedJun 27, 2024

NuFACE® FIX+

510(k) number: K240564
Applicant: Carol Cole Company Dba Nuface®
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 29, 2024

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.

FDA database record FDA document (PDF)

510(k) clearedFeb 24, 2021

Trinity ELE Plus and Trinity ELE Plus Pro

510(k) number: K201906
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jul 9, 2020

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedJan 22, 2021

NuFace Trinity Plus Device

510(k) number: K201782
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 30, 2020

Indications for use, as filed

“The NūFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedOct 15, 2019

NuFACE Mini Device

510(k) number: K191672
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 24, 2019

Indications for use, as filed

“The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedDec 18, 2018

NuFACE FIX Skin Toning Device

510(k) number: K182424
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 6, 2018

Indications for use, as filed

“The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedOct 11, 2018

NuFACE Trinity

510(k) number: K181008
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Apr 17, 2018

Indications for use, as filed

“The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedJul 31, 2017

NuBODY Skin Toning Device

510(k) number: K171588
Applicant: Carol Cole Company Dba Nuface
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 31, 2017

Indications for use, as filed

“NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

LED and light devices for wrinkles (OHS, 1)

510(k) clearedApr 2, 2022

Trinity Plus Wrinkle Reducer

510(k) number: K212947
Applicant: Carol Cole Company Dba Nuface
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 15, 2021

Indications for use, as filed

“The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held device intended for the reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

FDA database record FDA document (PDF)