510(k) K252913
K252913 is an FDA 510(k) premarket notification submitted by Sonomotion, Inc. for the device "Break Wave". The FDA issued a decision of Substantially Equivalent on January 12, 2026. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Sonomotion, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2026
- Date Received
- September 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device Class
- Class II
- Regulation Number
- 876.5990
- Review Panel
- GU
- Submission Type