Identity
- Trade Name
- Kernel FDA UDI
- Generic Name
- Hand-held ophthalmic crosslinking ultraviolet phototherapy unit FDA UDI
- Device Name
- The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only FDA UDI
- Model / Reference
- KN-5000D FDA UDI
- Description
- The 308nm Excimer System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06928798600414 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Hand-held ophthalmic crosslinking ultraviolet phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kernel by Xuzhou Kernel Medical Equipment Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Xuzhou Kernel Medical Equipment Co., Ltd.
Sources (1)
- FDA UDI d50aadf1-d9c2-4a63-9039-883be01b3392 34 fields · synced Jun 6, 2026