LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
FDA 510(k) K180343 · Bonraybio Co., Ltd.
510(k) numberK180343
Submission
- Device name
- LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
- Applicant
- Bonraybio Co., Ltd.
Taichung, TW - Received
- February 7, 2018
- Decision date
- November 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POV – Semen Analysis Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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.
Other 510(k)s with product code POV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252228 | Seaman Pro/SeamanPOV · Traditional | Checkcells, Inc. | 04/09/2026SE |
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV · Traditional | Bonraybio Co., Ltd. | 05/30/2025SE |
| K242388 | LensHooke X12 PRO Semen Analysis SystemPOV · Traditional | Bonraybio Co., Ltd. | 05/09/2025SE |
| K243114 | SQA-iOw Sperm Quality AnalyzerPOV · Dual Track | Medical Electronic Systems , Ltd. | 05/02/2025SE |
| K241628 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/29/2024SE |
| K220828 | SQA-iO Sperm Quality AnalyzerPOV · Traditional | Medical Electronic Systems , Ltd. | 08/07/2023SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | Bonraybio Co., Ltd. | 10/28/2020SE |
| K183602 | SwimCount Sperm Quality TestPOV · Traditional | Motilitycount Aps | 06/27/2019SE |
| K172514 | Trak Plus Male Fertility Testing SystemPOV · Traditional | Sandstone Diagnostics, Inc. | 11/17/2017SE |
| K161493 | YO Home Sperm TestPOV · Traditional | Medical Electronic Systems , Ltd. | 11/08/2016SE |
More from Medical Electronic Systems , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerPOV · Traditional | 05/30/2025SE |
| K242388 | LensHooke X12 PRO Semen Analysis SystemPOV · Traditional | 05/09/2025SE |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQK · Traditional | 10/31/2022SE |
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerPOV · Special | 10/28/2020SE |
Questions and answers
When was LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer cleared by the FDA?
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (K180343) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 282 days after the submission was received.
What is the product code of K180343?
The FDA product code is POV – Semen Analysis Device, a Class II (moderate risk) device regulated under 21 CFR 864.5220.