FDA.reportPublic FDA data

PAKISS

Primary DI
06975866360169
Brand
PAKISS
Company
Shenzhen Xiazhifeng Electronic Co., Ltd
Model
FY-B507AG
Published
2025-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K230549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230549000IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BGShenzhen Xiazhifeng Electronic Co., Ltd.2023-04-25OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975866360169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975866360169069758663601696975866360169

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.

Regulatory Flags#

DUNS number
550459500
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975866360107PAKISSFY-B507AL2025-03-11
06975866360114PAKISSFY-B505AG2025-03-11
06975866360138PAKISSFY-B509AL2025-03-11
06975866360152PAKISSFY-B508AL2025-03-11
06975866360176PAKISSFY-B505BG2025-03-11
06975866360183PAKISSFY-B507BL2025-03-11
06975866361012PAKISSFY-B505AL2025-03-11
06975866360015PAKISSFY-B509AG2025-03-05
06975866360022PAKISSFY-B508AG2025-03-05
06975866360039PAKISSFY-B505BL2025-03-05
06975866360046PAKISSFY-B505AG2025-03-05
06975866360053PAKISSFY-B509BG2025-03-05
06975866362002PAKISSFY-B3012023-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974639600464IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06974639600471IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06974639600488IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHT2026-08-27
06977357490171MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357491314MlayShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
06977357497941DREAMEShenzhen Mlay Intelligent Technology Co., Ltd.OHT2026-07-20
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