K243279
- 510(k) number
- K243279
- Device name
- DOLORCLAST Focused Shock Waves
- Applicant
- E.M.S Electro Medical Systems S.A CH
- Product code
- PZL — Extracorporeal Shock Wave Device For Treatment Of Di
- Decision date
- 2025-08-13
- Date received
- 2024-10-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243279.pdf
Official FDA record: K243279
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.