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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K252318
Device Name Insufflator (OPTO-IFL1000)
Applicant
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St., Daxu, Guicheng, Nanhai,
Foshan,  CN 528200
Applicant Contact Weijuan Guo
Correspondent
Guangdong Optomedic Technologies, Inc.
Suite 503, Bldg. A, Golden Valley Intellicreation
Community, # 2 Yonganbei St., Daxu, Guicheng, Nanhai,
Foshan,  CN 528200
Correspondent Contact Weijuan Guo
Regulation Number884.1730
Classification Product Code
HIF  
Date Received07/25/2025
Decision Date 04/16/2026
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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