K252913
- 510(k) number
- K252913
- Device name
- Break Wave
- Applicant
- Sonomotion, Inc. CA · US
- Product code
- LNS — Lithotriptor, Extracorporeal Shock-Wave, Urological
- Decision date
- 2026-01-12
- Date received
- 2025-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252913.pdf
Official FDA record: K252913
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.