DOLORCLAST Focused Shock Waves— 510(k) K243279

Name: FDA 510(k) clearance K243279
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K243279 for DOLORCLAST Focused Shock Waves, Substantially Equivalent on 2025-08-13. Applicant: E.M.S Electro Medical Systems S.A. Device class: 2.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code PZL
Device class: Class 2
Regulation: 21 CFR 878.4685
Advisory panel: General, Plastic Surgery
Date received: 2024-10-16
Decision date: 2025-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyon, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.