FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FTCLight, Ultraviolet, Dermatological

Product Code Classifications

CodeDeviceSpecialtyClass
FTCLight, Ultraviolet, DermatologicalGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K250425000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06946725599990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06946725599990069467255999906946725599990

GMDN Terms

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

Regulatory Flags

DUNS number
529691989
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06946725550038APKI-A1424-SP203PVA1424-SP203PV2026-03-19
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06946725550069APKI-A1501-SR203PUA1501-SR203PU2026-03-19
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06946725550113APKI-A0816-SY105PUA0816-SY105PU2026-03-19
06946725550137APKI-A0816-SP106PVA0816-SP106PV2026-03-19
06946725550144APKI-A0816-SP106PUA0816-SP106PU2026-03-19
06946725550151APKI-A0816-SW106PUA0816-SW106PU2026-03-19
06946725550168APKI-A0816-SR106PUA0816-SR106PU2026-03-19
06946725550182APKI-A0816-SY106PUA0816-SY106PU2026-03-19
06946725550199APKI-A0816-SA106MVA0816-SA106MV2026-03-19
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06946725550212APKI-A0816-SP106MVA0816-SP106MV2026-03-19

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