LensHooke X12 PRO Semen Analysis System
Bonraybio Co., LTD. is listed for LensHooke X12 PRO Semen Analysis System (K242388). The FDA list gives May 9, 2025 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code POV as “Semen Analysis Device”: Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242388
- Date of final decision
- May 9, 2025
- Company on the FDA list
- Bonraybio Co., LTD.
- Lead panel
- Hematology
- Primary product code
- POV
- openFDA device name for the code
- Semen Analysis Device
- Device class
- 2
- Regulation number
- 864.5220
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.