Break Wave
FDA 510(k) K252913 · Sonomotion, Inc.
510(k) numberK252913
Submission
- Device name
- Break Wave
- Applicant
- Sonomotion, Inc.
San Mateo, CA, US - Received
- September 12, 2025
- Decision date
- January 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5990
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261086 | Break WaveLNS · Special | Sonomotion, Inc. | 04/29/2026SE |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200)LNS · Traditional | Shenzhen Wikkon Precision Technologies Co., Ltd. | 06/18/2025SE |
| K221903 | Delta III ProLNS · Traditional | Dornier Medtech America, Inc. | 02/22/2023SE |
| K213772 | LM-9300 Plus LithotripterLNS · Traditional | Lite-Med, Inc. | 01/19/2023SE |
| K201001 | Modulith SLX-F2LNS · Traditional | Karl Storz Endoscopy America | 03/30/2021SE |
| K201074 | Delta III LithotripterLNS · Traditional | Dornier Medtech America, Inc. | 09/03/2020SE |
| K172084 | Delta III LithotripterLNS · Special | Dornier Medtech America, Inc. | 08/08/2017SE |
| K170122 | Delta III LithotripterLNS · Traditional | Dornier Medtech America | 06/28/2017SE |
| K151298 | Gemini XXP-HPLNS · Traditional | Dornier Medtech America | 07/30/2015SE |
| K142561 | LM-9300 ELMA LithotripterLNS · Abbreviated | Lite-Med, Inc. | 03/20/2015SE |
More from Lite-Med, Inc.
Questions and answers
When was Break Wave cleared by the FDA?
Break Wave (K252913) received a 510(k) decision of Substantially Equivalent on January 12, 2026, 122 days after the submission was received.
What is the product code of K252913?
The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.