FDA.reportPublic FDA data

Full Body Unit, 44 UVA Lamp Unit

Primary DI
B276V44000
Brand
Full Body Unit, 44 UVA Lamp Unit
Company
ULTRALITE ENTERPRISES INC
Model
V4400
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
B276V44000PrimaryHIBCC0

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
B276HFDL28A0Hand and Foot Unit, 28 UVA Lamp UnitHFDL28A2016-09-23
B276HFDL28NB0Hand and Foot Unit, 28 UVB Lamp UnitHFDL28NB2016-09-23
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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