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510(k) K243279

DOLORCLAST Focused Shock Waves by E.M.S Electro Medical Systems S.A — Product Code PZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2025
Date Received
October 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Device Class
Class II
Regulation Number
878.4685
Review Panel
SU
Submission Type

Treatment of diabetic foot ulcers

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  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)
  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)

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  • DEN160037 — dermaPACE System (December 28, 2017)