Zerigo Handheld System HD-02-1

GUDID 00865522000422

Patient access use to the Zerigo Home Light Therapy System, including the provision of the light-emitting device, for the treatment of chronic dermatological conditions such as Psoriasis, Vitiligo, and Eczema for a limited utilization period.

Zerigo Health, Inc.

Ultraviolet phototherapy unit, professional

• Primary Device ID: 00865522000422
• NIH Device Record Key: d6d7627a-658a-4d85-9492-3402c7e7f8ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zerigo Handheld System
• Version Model Number: HD-02
• Catalog Number: HD-02-1
• Company DUNS: 079513819
• Company Name: Zerigo Health, 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: false
• 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
GS1	00865522000415 [Previous]
GS1	00865522000422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170489

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: 2024-09-16
• Device Publish Date: 2024-09-06

On-Brand Devices [Zerigo Handheld System]

• 00865522000415: The Zerigo Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, V
• 00865522000422: Patient access use to the Zerigo Home Light Therapy System, including the provision of the light