Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006459199

FEI Number

3006459199

Entity Name

Carol Cole Company dba NuFACE

City/State/Country

Vista, CA, US

Establishment Address

1325 Sycamore Ave Ste B, Vista, CA 92081, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Carol Cole Company (Owner Number: 9106439)

Owner / Operator Contact Address

1325 Sycamore Ave Ste B, --, Vista, CA 92081, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201906

PMA Number

N/A

All Registered Proprietary Names

Labeling Information Pilot Program Participants Only Trinity Wrinkle Reducer Trinity Wrinkle Remover NuFACE Mini Facial and Neck Skin Toning Device NuFACE FIX Device FIX MicroWand (FIX+) Trinity Plus Facial Toning Device NuFACE Trinity Facial Toning Device Micro Dermal Tone MDT Professional Home Care Device NuFACE Mini+ NuFACE Classic NuFACE Trinity ELE+ Pro NuFACE Trinity ELE+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2018-10-26
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2013-11-04
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2019-11-13
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2017-08-10
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2019-01-17
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2024-12-06
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2012-10-23
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2022-11-10
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2013-11-04
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2021-03-23

Official Correspondent

Kimberly Morales

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carol Cole Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006459199. Last updated year: 2026. Please use registration number 3006459199 when referencing this establishment in official correspondence.