Taichung, TW · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| POV | — | — | — | 3 | 2025-05-30 |
| MQK | Labware, Assisted Reproduction | Class II | Obstetrics/Gynecology | 1 | 2022-10-31 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-30 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | POV | — | — |
| 2025-05-09 | K242388 | LensHooke X12 PRO Semen Analysis System | POV | — | — |
| 2022-10-31 | K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | MQK | Class II | Obstetrics/Gynecology |
| 2020-10-28 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | POV | — | — |