K242830
- 510(k) number
- K242830
- Device name
- LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
- Applicant
- Bonraybio Co., Ltd. TW
- Product code
- POV — Semen Analysis Device
- Decision date
- 2025-05-30
- Date received
- 2024-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K242830.pdf
Official FDA record: K242830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.