Bryan, OH, US · 5 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | Class II | General, Plastic Surgery | 5 | 2023-12-13 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-04-26 | Class II | Ongoing | Z-1074-2022 | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 … | — | 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 | Class II | Ongoing | Z-1073-2022 | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Mode… | — | 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… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-12-13 | K233811 | DT Controlled Phototherapy Equipment | FTC | Class II | General, Plastic Surgery |
| 2023-03-24 | K230382 | 3 Series NeoLux | FTC | Class II | General, Plastic Surgery |
| 2022-04-22 | K220840 | 1 Series Phototherapy Equipment | FTC | Class II | General, Plastic Surgery |
| 2021-11-04 | K212510 | 7 Series Phototherapy Device | FTC | Class II | General, Plastic Surgery |
| 2021-06-22 | K210881 | M Series Phototherapy Equipment | FTC | Class II | General, Plastic Surgery |