Needham, MA, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NVK | — | — | — | 1 | 2022-09-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-09-01 | Class II | Ongoing | Z-0324-2024 | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K rewo… | — | It has been found that potential unintended laser activation can occur without foot pedal depression. |