FDA.reportPublic FDA data

Hand and Foot Unit, 28 UVA Lamp Unit

Primary DI
B276HFDL28A0
Brand
Hand and Foot Unit, 28 UVA Lamp Unit
Company
ULTRALITE ENTERPRISES INC
Model
HFDL28A
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTCLight, Ultraviolet, Dermatological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B276HFDL28A0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
7709630594support@ultraliteuv.com

Regulatory Flags#

DUNS number
070327895
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B27672P08NB0Panelite Home Unit, 8 UVB Lamps72P08NB2016-09-23
B27672P12VB0Panelite Unit, 12 Visible Lamp Unit72P12VB2016-09-23
B276HFDL28NB0Hand and Foot Unit, 28 UVB Lamp UnitHFDL28NB2016-09-23
B276V44000Full Body Unit, 44 UVA Lamp UnitV44002016-09-23
B276V4422ANB0Full Body Unit, 44 Lamp UVA/UVB Combination UnitV4422ANB2016-09-23
B276V4444NB0Full Body Unit, 44 UVB lampsV4444NB2016-09-23
B276V48000Full Body Unit, 48 Lamp UVA UnitV48002016-09-23
B276V4824ANB0Full Body Unit, 48 UVA/UVB Combination UnitV4824ANB2016-09-23
B276V4848NB0Full Body Unit, 48 UVB LampsV4848NB2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06928798600445KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600452KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
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