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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
510(k) Number K243279
Device Name DOLORCLAST Focused Shock Waves
Applicant
E.M.S Electro Medical Systems S.A
Ch. De La Vuarpillière 31
Nyon,  CH 1260
Applicant Contact Vivian Yee
Correspondent
Heyer Regulatory Solutions
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number878.4685
Classification Product Code
PZL  
Date Received10/16/2024
Decision Date 08/13/2025
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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