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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 K223020
Device Name VS3-Iridium System (VS3-IR)
Applicant
Visionsense, Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 4934829
Applicant Contact Guy Wroclawski
Correspondent
Visionsense, Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 4934829
Correspondent Contact Guy Wroclawski
Regulation Number876.1500
Classification Product Code
OWN  
Date Received09/29/2022
Decision Date 10/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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