FDA.reportPublic FDA data

KERNEL

Primary DI
06928798600469
Brand
KERNEL
Company
Xuzhou Kernel Medical Equipment Co., Ltd.
Model
KN-4001A
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

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
K261775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261775000Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd.2026-07-21

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06928798600469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06928798600469069287986004696928798600469

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, professionalA mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).

Regulatory Flags#

DUNS number
530873660
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
06928798600476KERNELKN-4001B2026-07-29
06928798600483KERNELKN-4001AB2026-07-29
06928798600377KernelCN-308E2025-03-11
06928798600384KernelKN-4003B32025-03-11
06928798600391KernelKN-4003B42025-03-11
06928798600421KernelKN-5000H2025-03-11
06928798600438KernelKN-5000K2025-03-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06928798600476KERNELXuzhou Kernel Medical Equipment Co., Ltd.FTC2026-07-29
06928798600483KERNELXuzhou Kernel Medical Equipment Co., Ltd.FTC2026-07-29
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
06928798600438KernelXuzhou 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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