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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K260100
Device Name MOSES Raydar™
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Ruth Kuehn
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Ilana Sahnovsky
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/13/2026
Decision Date 05/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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