Solarc/SolRx 100-Series

GUDID B219120UVB0

Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-BROADBAND Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Der

Solarc Systems Inc

Ultraviolet phototherapy unit, home-use

• Primary Device ID: B219120UVB0
• NIH Device Record Key: 0fa31972-5c6b-44e2-b57e-aa1c157e5156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarc/SolRx 100-Series
• Version Model Number: 120UVB
• 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	B219120UVB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061589

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 100-Series]

• B219ARM1000: Positioning Arm Accessory for Solarc/SolRx 100-Series Ultraviolet Phototherapy Lamp Unit.
• B219120UVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-Narrowband Handheld Devic
• B219120UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-Narrowband Handheld Devic
• B219120UVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 2-BULB UVB-BROADBAND Handheld Device
• B219110UVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Devic
• B219110UVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Devic
• B219110UVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-BROADBAND Handheld Device