K242830 is an FDA 510(k) clearance for the LensHooke X3 PRO Semen Quality Analyzer. 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 30, 2025, 253 days after receiving the submission on September 19, 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 | K242830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2024 |
| Decision Date | May 30, 2025 |
| Days to Decision | 253 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. |