Devices · Bonraybio Co., Ltd.

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

Bonraybio Co., Ltd. is listed for LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer (K180343). The FDA list gives November 16, 2018 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code POV as “Semen Analysis Device”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180343

Official FDA database record

Date of final decision

November 16, 2018

Company on the FDA list

Bonraybio Co., Ltd.

Lead panel

Hematology

Primary product code

POV

openFDA device name for the code

Semen Analysis Device

Device class

2

Regulation number

864.5220

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary