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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K252913
Device Name Break Wave
Applicant
Sonomotion, Inc.
1600 W. Hillsdale Blvd., Suite 105
San Mateo,  CA  94402
Applicant Contact Oren Levy
Correspondent
Sonomotion, Inc.
1600 W. Hillsdale Blvd., Suite 105
San Mateo,  CA  94402
Correspondent Contact Emily Hergenreter
Regulation Number876.5990
Classification Product Code
LNS  
Date Received09/12/2025
Decision Date 01/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05701098
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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