FDA.reportPublic FDA data

ishine

Primary DI
06975773050061
Brand
ishine
Company
Shenzhen Ishine Technology Co., Ltd.
Model
skn006
Device description
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Published
2022-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K222537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222537000IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo LumiShenzhen Ishine Technology Company Limited2022-10-14OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975773050061PrimaryGS10
06975773050146Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975773050061069757730500616975773050061
06975773050146069757730501466975773050146

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.

Contacts#

Phone, Email table
PhoneEmail
+86-13823508753anchaohui@ishineco.com

Regulatory Flags#

DUNS number
620658743
Device count
50
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975773050016ishineskn0012022-11-22
06975773050023ishineRoseSkinCo Lumi2022-11-22
06975773050054ishineskn0052022-11-22
06975773050115ishineskn0012022-11-22
06975773050122ishineRoseSkinCo Lumi2022-11-22
06975773050139ishineskn0052022-11-22
06975773050146ishineskn0062022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974028410001ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410018ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410032ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974028410087ALLESILKShenzhen Huaruibo Electric Appliances Co., LtdOHT2026-07-08
06974667829554UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829561UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829578UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829608UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829615UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
06974667829622UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2026-06-10
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