Cleared Traditional

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

K180343 · Bonraybio Co., Ltd. · Hematology

Nov 2018

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K180343 is an FDA 510(k) clearance for the LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 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 November 16, 2018, 282 days after receiving the submission on February 7, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K180343 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2018
Decision Date	November 16, 2018
Days to Decision	282 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.