FDA.reportPublic FDA data

Numiere

Primary DI
00850018806701
Brand
Numiere
Company
Heatinaclick LLC
Model
6701
Device description
Time Keeper Wrinkle Reducing LED Face Mask
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K241857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241857000LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd2024-10-11OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018806701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018806701008500188067018500188067010850018806701

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, home-useAn electrically-powered, patient-worn device designed be used by a layperson in the home (may additionally be used by a healthcare professional in a clinical setting) to emit red light for phototherapy primarily to treat musculoskeletal symptoms (e.g., arthritis pain, spasm, stiffness) and increase muscle relaxation through localized modification of cellular metabolism and/or improvement of blood circulation. It is in the form of a wearable thin adhesive hydrogel patch with integrated light-emitting diodes (LEDs) designed to be applied to the affected area. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043038693
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018806541Lumina NRG65412025-01-31
00850018806572Lumina NRG65722025-01-31
00850018806602Numiere 66022025-01-31
00850018806619Lumina NRG66192025-01-31
00850018806626Lumina NRG66262025-01-31
00850018806664Numiere 66642025-01-31
00850018806800Fit Relief64042025-01-31
00850018806824Numiere 68242025-01-31

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Primary DI, Brand, Company table
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00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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