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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K242163
Device Name SmartSurgN Visualization System
Applicant
SmartsurgN, Inc.
1038 Leigh Ave. Suite 101b
San Jose,  CA  95126
Applicant Contact Jocelyn Long
Correspondent
SmartsurgN, Inc.
1038 Leigh Ave. Suite 101b
San Jose,  CA  95126
Correspondent Contact Jocelyn Long
Regulation Number876.1500
Classification Product Code
OWN  
Date Received07/24/2024
Decision Date 04/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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