K242388 is an FDA 510(k) clearance for the LensHooke X12 PRO Semen Analysis System. This device is classified as a Semen Analysis Device (Class II - Special Controls, product code POV).
Submitted by Bonraybio Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on May 9, 2025, 270 days after receiving the submission on August 12, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220. 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..
| 510(k) Number | K242388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2024 |
| Decision Date | May 09, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | POV - Semen Analysis Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| Definition | 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. |