FDA.reportPublic FDA data

Numiere

Primary DI
00850018806602
Brand
Numiere
Company
Heatinaclick LLC
Model
6602
Device description
Microcurrent & LED Tightening Sculpting & Wrinkle Reducing Device
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
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1718210002 Face / Face EvolutionHeat IN A Click2018-04-26NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018806602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018806602008500188066028500188066020850018806602

GMDN Terms#

Term, Definition table
TermDefinition
Facial muscle cosmesis electrical stimulatorAn electrically-powered, hand-held device intended to be used in the home to apply electrical stimuli to the facial muscles through the skin (transcutaneously), to improve muscle tone and help tighten overlying skin for cosmetic facial rejuvenation. It includes electrodes at the distal end and controls to adjust the electrical impulse intensity; it is typically used with a gel, which may be supplied with the device, intended to facilitate conduction of the electrical current. 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
00850018806619Lumina NRG66192025-01-31
00850018806626Lumina NRG66262025-01-31
00850018806664Numiere 66642025-01-31
00850018806701Numiere 67012025-01-31
00850018806800Fit Relief64042025-01-31
00850018806824Numiere 68242025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851367006224ZIIP BeautyZIIP, INC.NFO2026-04-22
00851530007621AvazziaAVAZZIA INCNFO2026-04-21
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06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
00817076014516bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014523bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014530bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
08908008085499Syrma Johari MedTech LimitedSYRMA JOHARI MEDTECH LIMITEDNFO2025-07-08
06974667825013JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825020JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825037JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07
06974667825044JMOONShenzhen Ulike Smart Electronics Co., Ltd.NFO2025-06-07