Cleared Traditional

LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer

K242830 · Bonraybio Co., Ltd. · Hematology

May 2025

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K242830 is an FDA 510(k) clearance for the LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer, 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 review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K242830 FDA.gov
FDA Decision	Cleared 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

Device Classification

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.