Solarc/SolRx 1000-Series

GUDID B2191780UVBNB0

Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, A

Solarc Systems Inc

Ultraviolet phototherapy unit, home-use

• Primary Device ID: B2191780UVBNB0
• NIH Device Record Key: a8fa72de-84dd-4375-8f33-2258e450a0aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarc/SolRx 1000-Series
• Version Model Number: 1780UVB-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	B2191780UVBNB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935572

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 1000-Series]

• B2191790UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 10-BULB UVB-Narrowband Full
• B2191780UVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full B
• B2191780UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full B
• B2191760UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-Narrowband Full B
• B2191760UVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-BROADBAND Full Bo
• B2191740UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-Narrowband Full B
• B2191740UVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 4-BULB UVB-BROADBAND Full Bo