AccessGUDID - DEVICE: Solarc/SolRx 100-Series (B219110UVBNB230V0)

GUDID

Device Identifier (DI) Information

Brand Name: Solarc/SolRx 100-Series
Version or Model: 110UVB-NB-230V
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Solarc Systems Inc

Primary DI Number: B219110UVBNB230V0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 256728031 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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.

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.

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061589	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 084d152e-766e-4e5d-b670-dd9e4aa30aec
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 17, 2016