DEVICE: Solarc/SolRx 1000-Series (B2191780UVBNB230V0)

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Device Identifier (DI) Information

Solarc/SolRx 1000-Series
1780UVB-NB-230V

Solarc Systems Inc
B2191780UVBNB230V0
HIBCC
1
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). For use with 220 to 240 volt supply power.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
FTC Light, Ultraviolet, Dermatological
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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Device Status

In Commercial Distribution
September 17, 2016

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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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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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