FDA.reportPublic FDA data

Numiere

Primary DI
00850018806824
Brand
Numiere
Company
Heatinaclick LLC
Model
6824
Device description
Numiere IPL Hair Removal with Ice Cooling
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
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240282000IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)Dongguan Boyuan Intelligent Technology Co.,Ltd2024-04-03OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018806824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018806824008500188068248500188068240850018806824

GMDN Terms#

Term, Definition table
TermDefinition
Home-use intense pulsed light hair removal unitA hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.

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
00850018806701Numiere 67012025-01-31
00850018806800Fit Relief64042025-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974667829738UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06974667829745UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06974667829752UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-05-27
06956822893044GOODWINDShenzhen Goodwind technology development Co.,LtdOHT2026-04-23
06956822893051GOODWINDShenzhen Goodwind technology development Co.,LtdOHT2026-04-23
00047400703117Braun Silk.expert Pro 5PROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
00047400703230Braun Silk.expert Pro 5PROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
00047400703360Braun Skin i-expertPROCTER & GAMBLE MANUFACTURING COMPANY, THEOHT2026-01-05
06974667821442UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667821459UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822852UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822869UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822876UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822883UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822890UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822906UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822913UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822920UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667822937UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823033UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823040UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823057UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823064UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667823071UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826287UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826294UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826300UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826317UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826324UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23
06974667826331UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-06-23