510(k) K180343
K180343 is an FDA 510(k) premarket notification submitted by Bonraybio Co., Ltd. for the device "LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer". The FDA issued a decision of Substantially Equivalent on November 16, 2018. 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
- November 16, 2018
- Date Received
- February 7, 2018
- 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.