FDA.reportPublic FDA data

Solarc/SolRx 100-Series

Primary DI
B219ARM1000
Brand
Solarc/SolRx 100-Series
Company
Solarc Systems Inc
Model
ARM-100
Device description
Positioning Arm Accessory for Solarc/SolRx 100-Series Ultraviolet Phototherapy Lamp Unit.
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
K061589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061589000SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILYSolarc Systems, Inc.2006-08-04FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B219ARM1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, home-useA mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home.

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
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
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