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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K221810
Device Name LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
Applicant
Bonraybio Co., Ltd.
4f., # 118, Gongye 9th Rd., Dali Dist.
Taichung,  TW 41280
Applicant Contact Clare Huang
Correspondent
Ivdd Regulatory Consultant
29122 Rancho Viejo Rd., Suite 212
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number884.6160
Classification Product Code
MQK  
Date Received06/22/2022
Decision Date 10/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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