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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K242830
Device Name LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Applicant
Bonraybio Co., Ltd.
4f., # 118, Gongye 9th Rd., Dali Dist.
Taichung,  TW 41280
Applicant Contact Clare Huang
Correspondent
Bonraybio Co., Ltd.
4f., # 118, Gongye 9th Rd., Dali Dist.
Taichung,  TW 41280
Correspondent Contact Clare Huang
Regulation Number864.5220
Classification Product Code
POV  
Date Received09/19/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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