FDA.reportPublic FDA data

MLAY

Primary DI
06970275250100
Brand
MLAY
Company
Shenzhen Mareal Tech Co.,Ltd
Model
T3
Published
2018-05-15
Public version status
Update
Distribution status
Not 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
K172883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172883000Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.2018-02-12OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970275250100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970275250100069702752501006970275250100

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544426063
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970275250087MLAYT12018-05-15
06970275250094MLAYT22018-05-15

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