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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears SonoMotion's Break Wave for Breaking Kidney Stones Without Anesthesia

The portable lithotripter, cleared on data from a 64-patient trial in which all procedures were done on awake patients, uses low-pressure focused ultrasound guided by real-time imaging.

By News DeskJanuary 22, 20262 min read
White SonoMotion Break Wave therapy probe with an imaging probe inserted through it
The Break Wave therapy probe with an ultrasound imaging probe mounted through its centre. Photo: SonoMotion · Press image distributed by SonoMotion with its PR Newswire release
FDA cleared510(k) · K252913FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared SonoMotion's Break Wave under 510(k) K252913 on January 12, 2026; the company announced it on January 21.
  • It is cleared to fragment stones in the kidney and ureter, the same indication as its predicate, a conventional shock wave lithotripter.
  • The 510(k) summary reports that a 64-patient single-arm trial met both co-primary endpoints, with a 70% cumulative success rate, and no procedures needed sedation or general anesthesia.

The US Food and Drug Administration has cleared SonoMotion's Break Wave, a portable device that breaks up kidney and ureteral stones with low-pressure focused ultrasound while the patient stays awake, the San Mateo, California, company announced on January 21 in a release distributed by PR Newswire.

The FDA's 510(k) database lists the clearance as K252913 for the Break Wave, classed as an extracorporeal shock-wave lithotripter under product code LNS. The agency received the submission on September 12, 2025, and found the device substantially equivalent on January 12, 2026.

How the device works

According to the clearance letter and 510(k) summary, the Break Wave is a lithotripter the size of a diagnostic ultrasound system. The operator scans the abdomen with an imaging probe to find the stone, then delivers focused acoustic waves that create stresses inside the stone until it fractures into fragments small enough to pass, watching the fragmentation in real time.

The device is "intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper and lower ureter)." The predicate is the Piezolith 3000 Triple-focus extracorporeal lithotripter, and the summary says the indication is the same. The differences it lists are a lower-amplitude, longer-duration acoustic pulse delivered at a higher rate.

Trial results

The summary describes a prospective, open-label, single-arm study of 64 patients at seven US and three Canadian sites, with stones larger than 4 mm and up to 10 mm in the upper urinary tract. Success was judged against two co-primary non-inferiority endpoints for safety and effectiveness compared with current shock wave lithotripsy outcomes, and both were met, the summary says.

The device achieved a 70% cumulative success rate for fragmenting upper urinary tract stones, according to the summary. It reports no device- or procedure-related clinically significant hematoma, urinary tract sepsis or cardiac arrhythmia, and one procedure-related serious adverse event. Procedures were performed without sedation or general anesthesia in all cases.

What SonoMotion says

SonoMotion said patients can drive themselves to and from the procedure and eat and drink beforehand. The company pairs Break Wave with Stone Clear, a device meant to help clear residual fragments, which it said received FDA clearance through the De Novo pathway in October 2024.

"This 510(k) clearance represents a significant step toward commercialization, and we look forward to scaling manufacturing and making our non-invasive, anesthesia-free solutions available to patients and providers across the urology community," said Oren Levy, SonoMotion's co-founder and chief executive, in the release. He credited support from investors, NASA and the NIH.

The company said it will show the platform at the American Urological Association meeting in Washington, DC, in May. The release was also republished by UroToday on January 21. SonoMotion did not disclose pricing or a launch date.

Sources

  1. SonoMotion Announces FDA Clearance for its Break Wave Lithotripsy Device for Treatment of Kidney Stones, SonoMotion via PR Newswire, January 21, 2026
  2. 510(k) K252913: Break Wave (database record), US Food and Drug Administration, January 12, 2026
  3. K252913 clearance letter and 510(k) summary, US Food and Drug Administration, January 12, 2026