Solarc/SolRx E-Series

GUDID B219E760AUVBNB0

Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband ADD-ON device, Expandable/Modular & Multi-directional Full Body Panels. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).

Solarc Systems Inc

Ultraviolet phototherapy unit, home-use

• Primary Device ID: B219E760AUVBNB0
• NIH Device Record Key: 90d3b775-5ffe-4461-834e-1ccca949a7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solarc/SolRx E-Series
• Version Model Number: E760A-UVBNB
• 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	B219E760AUVBNB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103204

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

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

• B219E720MUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-Narrowband MASTER de
• B219E720MUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-Narrowband MASTER de
• B219E720MUVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-BROADBAND MASTER dev
• B219E720AUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-Narrowband ADD-ON de
• B219E720AUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-Narrowband ADD-ON de
• B219E720AUVB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 2-Bulb UVB-BROADBAND ADD-ON dev
• B219E760MUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband MASTER de
• B219E760MUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband MASTER de
• B219E760AUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband ADD-ON de
• B219E760AUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband ADD-ON de
• B219E740MUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 4-Bulb UVB-Narrowband MASTER de
• B219E740MUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 4-Bulb UVB-Narrowband MASTER de
• B219E740AUVBNB230V0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 4-Bulb UVB-Narrowband ADD-ON de
• B219E740AUVBNB0: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 4-Bulb UVB-Narrowband ADD-ON de