FDA.reportPublic FDA data

Ulike

Primary DI
06974667829110
Brand
Ulike
Company
Shenzhen Ulike Smart Electronics Co., Ltd.
Model
UM10
Published
2026-03-26
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
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260511000Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.2026-03-16OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974667829117PackageGS18In Commercial Distribution
06974667829110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697466782911716974667829117
06974667829110069746678291106974667829110

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.

Regulatory Flags#

DUNS number
618646978
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974667829738UlikeUI06S PRU2026-05-27
06974667829745UlikeUI06S PNU2026-05-27
06974667829752UlikeUI06S WHU2026-05-27
06974667827147UlikeUI06 WH2025-12-10
06974667827154UlikeUI06 PR2025-12-10
06974667827161UlikeUI06 PN2025-12-10
06974667827567UlikeUI20S PW2025-12-10
06974667827574UlikeUI20S GP2025-12-10
06974667827581UlikeUI20 WH2025-12-10
06974667827598Ulike UI20 GR2025-12-10
06974667827604Ulike UI20 BS2025-12-10
06974667827611UlikeUI20 MP2025-12-10
06974667827628UlikeUI20 BL2025-12-10
06974667827635UlikeUI20 PN2025-12-10
06974667827659UlikeUI20 WG2025-12-10
06974667827666UlikeUI20S WH2025-12-10
06974667827680UlikeUI20S BS2025-12-10
06974667827697UlikeUI20S MP2025-12-10
06974667827703UlikeMI01 LP2025-12-10
06974667827710UlikeMI01 CB2025-12-10

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Primary DI, Brand, Company table
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08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOLP2026-04-23
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
00850523007365CellumaBiophotas, Inc.OLP2026-04-06
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05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
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07640260120617FAQ Dual LED PanelForeo ABOLP2026-03-02
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOHS2026-02-06
16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
16978368600105LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
06956822893013SolawaveShenzhen Goodwind technology development Co.,LtdOHS2026-02-04
05060555750756LYMA LaserLYMA LIFE LIMITEDOLP2026-01-28
00811485037210PMDShenzhen Fittop Health Technology Co., Ltd.OLP2026-01-16
06920473100820ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100837ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100844ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100851ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
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06920473100875ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100882ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100899ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
06920473100905ACE-TECGuangdong Ace-Tec Co.,LtdOLP2026-01-15
00850020752492NIRA Bundle +Nira Innovations IncorporatedOHS2025-11-19