Break Wave— 510(k) K261086
Substantially EquivalentSonomotion, Inc.
FDA 510(k) clearance K261086 for Break Wave, Substantially Equivalent on 2026-04-29. Applicant: Sonomotion, Inc.. Device class: 2.
Summary
Break Wave comes from Sonomotion, Inc. and is filed under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 876.5990. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Special 510(k).
Sonomotion filed from San Mateo, California. The record shows 28 calendar days from receipt to decision (April 1 to April 29, 2026).
Clearance details
- Applicant
- Sonomotion, Inc.
- Product code
- Product code LNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5990
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Mateo, CA, US
Recent devices under product code LNS
view allMore clearances from Sonomotion, Inc.
view allAdverse events under product code LNS
product code LNS- Death
- 4
- Injury
- 320
- Total
- 324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.