DEVICE: Solarc/SolRx 100-Series (B219110UVBNB230V0)
Device Identifier (DI) Information
Solarc/SolRx 100-Series
110UVB-NB-230V
In Commercial Distribution
Solarc Systems Inc
110UVB-NB-230V
In Commercial Distribution
Solarc Systems Inc
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). For use with 220 to 240 volt supply power.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Ultraviolet phototherapy unit | A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended 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). |
Ultraviolet phototherapy unit, home-use | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
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FTC | Light, Ultraviolet, Dermatological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
084d152e-766e-4e5d-b670-dd9e4aa30aec
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined