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Carol Cole Company

5 FDA records filed under this company name, from 2007 to 2014, in microcurrent and ems (NFO, 4), light for wrinkles (OHS, 1).

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, 4)

510(k) cleared

NUFACE MINI DEVICE

510(k) number
K133823
Applicant
Carol Cole Company
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

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 9.

510(k) cleared

TRINITY ELE

510(k) number
K131251
Applicant
Carol Cole Company
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

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 1.

510(k) cleared

NUFACE PLUS

510(k) number
K103472
Applicant
Carol Cole Company
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

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.

510(k) cleared

NUFACE, MODEL NU-4003

510(k) number
K072260
Applicant
Carol Cole Company
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

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.

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

TRINITY WRINKLE REMOVER

510(k) number
K120560
Applicant
Carol Cole Company
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

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.