FDA.reportPublic FDA data

carevia

Primary DI
06978874940033
Brand
carevia
Company
Alovea Healthcare Co., Ltd.
Model
I6 D1
Device description
IPL Hair Removal Device
Published
2025-12-17
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
K252618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252618000IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co. , Ltd.2025-11-14OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978874940033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978874940033069788749400336978874940033

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
450425100
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978874940019careviaI6 M12025-12-17
06978874940026careviaI6 S12025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.OHT2026-06-05
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