Bonraybio Co., Ltd. · Class II · Cleared May 9, 2025
| K-number | K242388 |
| Device name | LensHooke X12 PRO Semen Analysis System |
| Applicant | Bonraybio Co., Ltd. |
| Product code | POV |
| Device class | Class II |
| Decision date | May 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 864.5220 |
The LensHooke X12 PRO Semen Analysis System is an optical device for automated human semen analysis that measures sperm concentration, motility (progressive and total), morphology, and DNA fragmentation index. It integrates optical design with artificial intelligence image processing to analyze semen quality in clinical laboratory settings for male fertility evaluation.
The subject device is a desktop unit with light sources, built-in video microscopy, and an internal computer with algorithms for semen parameter assessment. It adds Ethernet connectivity to the predicate's HDMI/USB interfaces and uses slide-based consumables (CS3 10μm slides, SCD and SDFR assays) rather than cassette-based ones, while maintaining the same core optical microscopy and algorithmic analysis technology.
Not stated in this summary.
The subject device is substantially equivalent because it performs the same intended functions (sperm concentration, motility, morphology analysis, and DNA fragmentation measurement) using the same core optical microscopy and algorithmic technology as the predicate LensHooke X1 PRO. Both are non-comprehensive male fertility assessment tools for clinical laboratory use by professionals. Performance testing—including repeatability, reproducibility, linearity, interference, and user performance studies—demonstrated functional and accuracy equivalence to the predicate device.
View the full FDA submission: accessdata.fda.gov