Clearance Summary
LensHooke X12 PRO Semen Analysis System received FDA 510(k) clearance under submission number K242388, sponsored by Bonraybio Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2025-05-09.
- Submission: K242388
- Applicant / Sponsor: Bonraybio Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2025-05-09
Classification & Regulation
This clearance is catalogued under FDA product code POV and 21 CFR 864.5220, within the Hematology review panel as a Class II device.