Laguna Hills, CA, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KIF | — | — | — | 1 | 2021-08-27 |
| ELC | — | — | — | 1 | 2021-02-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-10-14 | Class II | Ongoing | Z-0234-2023 | GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 | — | Procedure Instruments with erroneous unit carton labels. |
| 2022-10-14 | Class II | Ongoing | Z-0233-2023 | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | — | Procedure Instruments with erroneous unit carton labels. |