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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 K152204
Device Name VS3-IR system
Applicant
Visionsense, Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 49348
Applicant Contact ALEX CHANIN
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number876.1500
Classification Product Code
OWN  
Subsequent Product Codes
GCJ   GWG   HRX  
Date Received08/06/2015
Decision Date 10/28/2015
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 Yes
Predetermined Change
Control Plan Authorized		 No
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