510(k) K242388
K242388 is an FDA 510(k) premarket notification submitted by Bonraybio Co., Ltd. for the device "LensHooke X12 PRO Semen Analysis System". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Bonraybio Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2025
- Date Received
- August 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semen Analysis Device
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
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.