Cleared Special

LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

K202089 · Bonraybio Co., Ltd. · Hematology

Oct 2020

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K202089 is an FDA 510(k) clearance for the LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 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 October 28, 2020, 92 days after receiving the submission on July 28, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K202089 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2020
Decision Date	October 28, 2020
Days to Decision	92 days
Submission Type	Special
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.