Identity
- Trade Name
- Zerigo Handheld System FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, professional FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- HD-02 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- HD-02-1 FDA UDI
- Primary DI / UDI-DI
- 00865522000422 FDA UDI
- 510(k) Number
- K170489 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultraviolet phototherapy unit, professional
Zerigo Handheld System by Zerigo Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170489 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zerigo Health, Inc.
Sources (1)
- FDA UDI d6d7627a-658a-4d85-9492-3402c7e7f8ec 35 fields · synced Jun 1, 2026