Solarc/SolRx 500-Series

GUDID B219540UVBNB0

Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 4-BULB UVB-Narrowband Hand/Foot&Spot Mid-Size Device. Indications for Use: Psoriasis, Viti

Solarc Systems Inc

Ultraviolet phototherapy unit, home-use

• Primary Device ID: B219540UVBNB0
• NIH Device Record Key: 086e4e70-bb82-4df1-8f4c-5c2ee0433efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarc/SolRx 500-Series
• Version Model Number: 540UVB-NB
• Company DUNS: 256728031
• Company Name: Solarc Systems Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B219540UVBNB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031800

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2016-09-17

On-Brand Devices [Solarc/SolRx 500-Series]

• B219550UVBNBCR0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 5-BULB UVB-Narrowband Hand/Foot&Spot
• B219550UVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 5-BULB UVB-Narrowband Hand/Foot&Spot
• B219550UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 5-BULB UVB-Narrowband Hand/Foot&Spot
• B219550UVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 5-BULB UVB-BROADBAND Hand/Foot&Spot
• B219540UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 4-BULB UVB-Narrowband Hand/Foot&Spot
• B219530UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 3-BULB UVB-Narrowband Hand/Foot&Spot
• B219520UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 500-Series 2-BULB UVB-Narrowband Hand/Foot&Spot