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Light, Ultraviolet, Dermatological
FDA product code FTC · Class 2 · General, Plastic Surgery
775
Registered devices
120
Adverse events
15
Recalls
272
510(k) clearances
Devices with this code
Full Body Unit, 48 UVA/UVB Combination Unit — ULTRALITE ENTERPRISES INCDAAVLIN — DAAVLIN DISTRIBUTING CO., THEKernel — Xuzhou Kernel Medical Equipment Co., Ltd.DAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THESolarc/SolRx E-Series — Solarc Systems IncDAAVLIN — DAAVLIN DISTRIBUTING CO., THENational Biological Corporation — NATIONAL BIOLOGICAL CORPORATIONDAAVLIN — DAAVLIN DISTRIBUTING CO., THENational Biological Corporation — NATIONAL BIOLOGICAL CORPORATIONDAAVLIN — DAAVLIN DISTRIBUTING CO., THEilluvinate System — LUMA THERAPEUTICS, INC.DAAVLIN — DAAVLIN DISTRIBUTING CO., THETip ClearLift QS 5x5 without Depth Control Set (Female) — ALMA LASERS LTD.National Biological Corporation — NATIONAL BIOLOGICAL CORPORATIONSolarc/SolRx E-Series — Solarc Systems IncDAAVLIN — DAAVLIN DISTRIBUTING CO., THEDAAVLIN — DAAVLIN DISTRIBUTING CO., THE
Recent 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 inst |
| 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 inst |
| 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 inst |
| 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 dos |
| 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 dos |
| 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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