FDA.reportPublic FDA data

Ulike

Primary DI
16974667822118
Brand
Ulike
Company
Shenzhen Ulike Smart Electronics Co., Ltd.
Model
UM10
Published
2025-06-06
Public version status
New
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243492000Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.2025-01-10OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974667822118PackageGS18In Commercial Distribution
06974667822111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697466782211816974667822118
06974667822111069746678221116974667822111

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
618646978
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974667829738UlikeUI06S PRU2026-05-27
06974667829745UlikeUI06S PNU2026-05-27
06974667829752UlikeUI06S WHU2026-05-27
06974667829110UlikeUM102026-03-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
06974020961372BrookstoneGuangdong Newdermo Biotech Co.,Ltd.OHS2026-05-28
06980088700006KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700013KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
06980088700020KakusanSZ KKS Silicone&Electronic Co.,LtdOHS2026-05-13
18712856075024Silk'nSilkn Beauty Ltd.OHS2026-05-07
00850001456784MODEL S+ BY SPIRULUX Omm Imports Inc.OHS2026-05-03
00850001456791PRO MED BY JOUVALLE Omm Imports Inc.OHS2026-05-02
08056389701115YOUNG AGAINESPANSIONE MARKETING SPAOHS2026-04-30
B347202366010Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366020Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
B347202366030Dr Dennis Gross SkincareLED TECHNOLOGIES INCOHS2026-04-23
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990143NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990150NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
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06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
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06977168990273NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06974958310549ideatherapyShenzhen Idea Light LimitedOHS2026-04-17
06974958310556LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06974958310563LIFEPRO FITNESSShenzhen Idea Light LimitedOHS2026-04-17
06978368600221DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600238DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07
06978368600245DreameShenzhen Rainbow Technology Co.,LtdOHS2026-04-07