FDA.reportPublic FDA data

Solarc/SolRx E-Series

Primary DI
B219E720MUVB0
Brand
Solarc/SolRx E-Series
Company
Solarc Systems Inc
Model
E720M-UVB
Device description
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-BROADBAND MASTER device, Expandable/Modular & Multi-directional Full Body Panels. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Published
2016-09-17
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
K103204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103204000SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILYSolarc Systems, Inc.2011-04-27FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B219E720MUVB0PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
256728031
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B219E780MUVBNB0Solarc/SolRx E-SeriesE780M-UVBNB2025-04-01
B219E790MUVBNB0Solarc/SolRx E-SeriesE790M-UVBNB2025-04-01
B219E740AUVBNB0Solarc/SolRx E-SeriesE740A-UVBNB2023-09-18
B219E740AUVBNB230V0Solarc/SolRx E-SeriesE740A-UVBNB-230V2023-09-18
B219E740MUVBNB0Solarc/SolRx E-SeriesE740M-UVBNB2023-09-18
B219E740MUVBNB230V0Solarc/SolRx E-SeriesE740M-UVBNB-230V2023-09-18
B219E760AUVBNB0Solarc/SolRx E-SeriesE760A-UVBNB2023-09-18
B219E760AUVBNB230V0Solarc/SolRx E-SeriesE760A-UVBNB-230V2023-09-18
B219E760MUVBNB0Solarc/SolRx E-SeriesE760M-UVBNB2023-09-18
B219E760MUVBNB230V0Solarc/SolRx E-SeriesE760M-UVBNB-230V2023-09-18
B219110UVB0Solarc/SolRx 100-Series110UVB2016-09-17
B219110UVBNB0Solarc/SolRx 100-Series110UVB-NB2016-09-17
B219110UVBNB230V0Solarc/SolRx 100-Series110UVB-NB-230V2016-09-17
B219120UVB0Solarc/SolRx 100-Series120UVB2016-09-17
B219120UVBNB0Solarc/SolRx 100-Series120UVB-NB2016-09-17
B219120UVBNB230V0Solarc/SolRx 100-Series120UVB-NB-230V2016-09-17
B2191740UVB0Solarc/SolRx 1000-Series1740UVB2016-09-17
B2191740UVBNB0Solarc/SolRx 1000-Series1740UVB-NB2016-09-17
B2191760UVB0Solarc/SolRx 1000-Series1760UVB2016-09-17
B2191760UVBNB0Solarc/SolRx 1000-Series1760UVB-NB2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971782583385Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
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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
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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
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