FDA.reportPublic FDA data

UVBioTek

Primary DI
B343B20
Brand
UVBioTek
Company
Medtek Lighting Corporation
Model
20B
Catalog number
20B
Device description
"Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72"" Lamps. Mounts to Wall."
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K134009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134009000UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONALMedtek Lighting2014-10-15FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B343B20PrimaryHIBCC0

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area621Square inch
Weight40Pound

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002692106
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B343ML600UVBioTekMobile LiteML6002017-02-09
B3437000A1POLY7000A2017-08-31
B3437000A2Poly ProPoly Pro Rejuv2018-09-19
B3437000A3POLY ProRegen2018-10-31
B3437000C1Poly Go7000C2017-09-01
B3437000C21Poly Spot7000C22017-09-01
B3437000CA1POLY GoPOLY Go Clear2018-09-17
B343B100UVBioTek100B100B2017-02-09
B343B1600UVBioTek1600B1600B2017-02-09
B343B2400UVBioTek2400B2400B2017-02-09
B343B3200UVBioTek3200B3200B2017-02-09
B343B40UVBioTek40B40B2017-02-09
B343B4000UVBioTek4000B4000B2017-02-09
B343B60UVBioTerk60B60B2017-02-09
B343B80UVBioTek80B80B2017-02-09
B343B800UVBioTek800B800B2017-02-09
B343MD3UVBioTekMulti DirectionalMD32017-02-09
B343VL1400UVBioTekVersa-Lite 1400VL14002017-02-09
B343CT2000Peacock Tanning2000CT2000CT2017-02-09
B343CT3200Peacock Tanning3200CT3200CT2017-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00810182930138DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930145DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12