FDA.reportPublic FDA data

UVBioTek

Primary DI
B343B100
Brand
UVBioTek
Company
Medtek Lighting Corporation
Model
100B
Catalog number
100B
Device description
Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand.
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
B343B100PrimaryHIBCC0

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 Area1311Square inch
Weight180Pound

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
B343B1600UVBioTek1600B1600B2017-02-09
B343B20UVBioTek20B20B2017-02-09
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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