Aurora

GUDID B780AUR20000

The Aurora is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

PSORIA-SHIELD INC.

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• Primary Device ID: B780AUR20000
• NIH Device Record Key: 1e111896-8c97-4deb-a335-a3952fe64448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aurora
• Version Model Number: 2000
• Company DUNS: 962442633
• Company Name: PSORIA-SHIELD INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B780AUR20000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192411

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological
• GEX: Powered Laser Surgical Instrument

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: 2020-08-20
• Device Publish Date: 2020-08-12