FDA.reportPublic FDA data

APK

Primary DI
06946725599990
Brand
APK
Company
APK Technology Co.,Ltd.
Model
AUC004
Device description
Ultraviolet Phototherapy Device
Published
2025-09-22
Public version status
New
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
K250425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250425000Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.2025-04-07FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06946725599990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06946725599990069467255999906946725599990

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529691989
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946725538005APKA1414-SR103PU2026-09-04
06946725548998APKA1418-SA03M042026-09-04
06946725572276APKA1414-SN03012026-09-04
06946725572283APKA501P-EK2PH2026-09-04
06946725572221APKS110-21M02026-08-21
06946725512173APKA2417-EZ92026-08-14
06946725513521APKA-CO-2102026-08-14
06946725555262APKA1414-ES2026-08-14
06946725568439APKA-CO-1572026-08-14
06946725568446APKA-CO-1582026-08-14
06946725568453APKA-CO-1592026-08-14
06946725568460APKA-CO-1602026-08-14
06946725568477APKA-CO-1612026-08-14
06946725568484APKA-CO-1622026-08-14
06946725568491APKA-CO-1632026-08-14
06946725568507APKA-CO-1642026-08-14
06946725568514APKA-CO-1652026-08-14
06946725568521APKA-CO-1662026-08-14
06946725568538APKA-CO-1692026-08-14
06946725568545APKA-CO-169-012026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06928798600469KERNELXuzhou Kernel Medical Equipment Co., Ltd.FTC2026-07-29
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
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
00810182930930DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-13
00810182930008DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930015DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930022DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930039DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930046DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930053DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930060DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930077DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930084DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930091DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930107DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930114DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930121DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12