| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2025-05-30 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., LTD. | Hematology |
| 2025-05-09 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., LTD. | Hematology |
| 2020-10-28 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology |
| 2018-11-16 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology |