Leoni Fiber Optics GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0577-2019 | Class II | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Pri | October 17, 2018 |
| Z-0578-2019 | Class II | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private l | October 17, 2018 |
| Z-0580-2019 | Class II | Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private lab | October 17, 2018 |
| Z-0581-2019 | Class II | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber | October 17, 2018 |
| Z-0579-2019 | Class II | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private lab | October 17, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable | April 2, 2021 |