FDA.reportPublic FDA data

NuFACE

Primary DI
00850019720662
Brand
NuFACE
Company
Nuface
Model
42015
Device description
Trinity+ w/TWR+ Kit
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201782000
K212947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201782000NuFace Trinity Plus DeviceCarol Cole Company Dba Nuface2021-01-22NFO
K212947000Trinity Plus Wrinkle ReducerCarol Cole Company Dba Nuface2022-04-02OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019720662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019720662008500197206628500197206620850019720662

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023980008
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075943276NuFACE421942026-01-27
00810075944570NuFACE422512026-01-27
00810075944952NuFACE422602025-08-28
00810075941418NuFACE421162023-06-08
00810075941449NuFACE420192023-06-08
00850019720228NuFACE420002023-06-08
00850019720235NuFACE420012023-06-08
00850019720280NuFACE420062023-06-08
00850019720303NuFACE420082023-06-08
00850019720556NuFACE420102023-06-08
00850019720563NuFACE420112023-06-08
00850019720655NuFACE420162023-06-08
00850019720679NuFACE420202023-06-08
00810075940121NuFACE420712021-03-19
00810075940145NuFACE420732021-03-19
00810075940176NuFACE420742021-03-19
00810075940183NuFACE420772021-03-19
00810075940206NuFACE420792021-03-19
00810075940213NuFACE420822021-03-19
00810075940237NuFACE420802021-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
00851530007638AvazziaAVAZZIA INCNFO2026-04-21
06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990143NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990167NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990181NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21