Cleared Traditional

LensHooke X12 PRO Semen Analysis System

K242388 · Bonraybio Co., Ltd. · Hematology

May 2025

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K242388 is an FDA 510(k) clearance for the LensHooke X12 PRO Semen Analysis System, 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 9, 2025, 270 days after receiving the submission on August 12, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K242388 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2024
Decision Date	May 09, 2025
Days to Decision	270 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.