FDA.reportPublic FDA data

NuFACE

Primary DI
00850019720303
Brand
NuFACE
Company
Nuface
Model
42008
Device description
TWR+ Attachment
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212947000Trinity Plus Wrinkle ReducerCarol Cole Company Dba Nuface2022-04-02OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019720303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019720303008500197203038500197203030850019720303

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
00850019720556NuFACE420102023-06-08
00850019720563NuFACE420112023-06-08
00850019720655NuFACE420162023-06-08
00850019720662NuFACE420152023-06-08
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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10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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