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-5000C 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
- 06928798600407 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
MR Safe 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 89abd41f-6367-483e-9076-c6b0d2104895 34 fields · synced May 31, 2026