Bonraybio Co., Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer510(k)May 30, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	May 30, 2025
LensHooke X12 PRO Semen Analysis System510(k)May 9, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	May 9, 2025
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device510(k)Oct 31, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2022