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Kernel
Xuzhou Kernel Medical Equipment Co., Ltd. · Model KN-5000C · UDI-DI 06928798600407
FTC
Prescription
10
510(k) clearances
120
Adverse events (1 deaths)
15
Recalls
26
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-05 | Daavlin Distributing Company | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). |
| 2026-03-05 | Daavlin Distributing Company | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). |
| 2026-03-05 | Daavlin Distributing Company | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). |
| 2025-12-10 | Daavlin Distributing Company | Some of the Calibration/Output Certificates had the outputs reversed. |
| 2022-04-26 | Daavlin Distributing Company | Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. |
| 2022-04-26 | Daavlin Distributing Company | Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing. |
| 2017-01-27 | National Biological Corp | The wiring may allow the lamps to turn on with the key switch rather than the timer. |
| 2013-04-09 | National Biological Corp | The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. |
| 2013-04-08 | National Biological Corp | The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. |
| 2008-02-19 | National Biological Corp | Software allows operator to override "low line voltage" error warning and store light intensity value. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.