FDA.reportPublic FDA data

Kernel

Primary DI
06928798600438
Brand
Kernel
Company
Xuzhou Kernel Medical Equipment Co., Ltd.
Model
KN-5000K
Published
2025-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTCLight, Ultraviolet, Dermatological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTCLight, Ultraviolet, DermatologicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242977000308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.2025-02-06FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06928798600438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06928798600438069287986004386928798600438

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, home-useA mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530873660
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06928798600377KernelCN-308E2025-03-11
06928798600384KernelKN-4003B32025-03-11
06928798600391KernelKN-4003B42025-03-11
06928798600421KernelKN-5000H2025-03-11
06928798600445KernelKN-5000C2025-03-11
06928798600452KernelKN-5000D2025-03-11
06928798600018KernelKN-4003AL2016-07-12
06928798600025KernelKN-4003B2016-07-12
06928798600032KernelKN-4003BL2016-07-12
06928798600049KernelKN-4006AL2016-07-12
06928798600056KernelKN-4006B2016-07-12
06928798600063KernelKN-4006BL2016-07-12
06928798600070KernelKN-4003AL22019-03-08
06928798600087KernelKN-4003BL22019-03-08
06928798600094KernelKN-4003AL2D2019-03-08
06928798600100KernelKN-4003BL2D2019-03-08
06928798600117KernelKN-4003AL2S2019-03-08
06928798600124KernelKN-4003BL2S2019-03-08
06928798600131KernelKN-4003AL2DS2019-03-08
06928798600148KernelKN-4003BL2DS2019-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971782583385Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583392Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583408Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583415Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06946725599990APKAPK Technology Co.,Ltd.FTC2025-09-22
B219E780MUVBNB0Solarc/SolRx E-SeriesSolarc Systems IncFTC2025-04-01
B219E790MUVBNB0Solarc/SolRx E-SeriesSolarc Systems IncFTC2025-04-01
06928798600377KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600384KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600391KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600421KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600445KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600452KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
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