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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Assisted Reproduction Laser
510(k) Number K253333
Device Name Assisted Reproduction Laser System (Model ILS-400M)
Applicant
Hua Yue Medical Technology Co., Ltd.
First Floor, C2 Bldg., #11 Kaiyuan Rd.
Huangpu District
Guangzhou,  CN 510530
Applicant Contact Zhenzhi Shi
Correspondent
Hua Yue Medical Technology Co., Ltd.
First Floor, C2 Bldg., #11 Kaiyuan Rd.
Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Zhenzhi Shi
Regulation Number884.6200
Classification Product Code
MRX  
Date Received09/30/2025
Decision Date 06/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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