DEVICE: Solarc/SolRx 500-Series (B219550UVBNBCR0)

Device Identifier (DI) Information

Solarc/SolRx 500-Series
550UVB-NB-CR
In Commercial Distribution

Solarc Systems Inc
B219550UVBNBCR0
HIBCC

1
256728031 *Terms of Use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 5-BULB UVB-Narrowband Hand/Foot&Spot Mid-Size Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). Clinic Rated (CR).
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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, 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.
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).
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FDA Product Code

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Product Code Product Code Name
FTC Light, Ultraviolet, Dermatological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K031800 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3334c026-7a81-4183-8cce-59dbdde007e6
July 06, 2018
3
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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)

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Yes
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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