FDA.reportPublic FDA data

Kakusan

Primary DI
06980088700013
Brand
Kakusan
Company
SZ KKS Silicone&Electronic Co.,Ltd
Model
kks-280
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K254007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254007000LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)SZ KKS Silicone&Electronic Co., Ltd.2026-02-12OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980088700013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980088700013069800887000136980088700013

GMDN Terms#

Term, Definition table
TermDefinition
Blue/red/infrared phototherapy lampA portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
546984470
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06980088700006Kakusankks-2252026-05-13
06980088700020Kakusankks-2812026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980088700006KakusanSZ 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
06977168990167NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990174NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
06977168990181NuonShenzhen Nuon Medical Equipment Co., Ltd.OHS2026-04-21
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
00850523007365CellumaBiophotas, Inc.OHS2026-04-06
05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
06974667829110UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHS2026-03-26
00850001456746Quantum Omm Imports Inc.OHS2026-03-02
07640260120600FAQ LED PanelForeo ABOHS2026-03-02
07640260120617FAQ Dual LED PanelForeo ABOHS2026-03-02
06979826590016PMDDongguan Hunter Electronic Technology Co., Ltd.OHS2026-02-26
06979826590023PMDDongguan Hunter Electronic Technology Co., Ltd.OHS2026-02-26