EXCI308 by Aerolase
CLARTEIS · Model EIPL-100 · UDI-DI 03760313461017
FTC
Prescription
1
510(k) clearances
120
Adverse events (1 deaths)
15
Recalls
26
Facilities
Description
Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
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.