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308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd. · Model XECL-308C, XECL-308D · UDI-DI 06971777450036
1
510(k) clearances
120
Adverse events (1 deaths)
15
Recalls
26
Facilities
Description
308nm Excimer System is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. It displays the treatment parameters. Users can set the device and fluence on the control touch screen and determine the machine's state and function under the help of colour-coded indicator light.
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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