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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 K252529
Device Name Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Brandon Burris
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Brandon Burris
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/11/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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