Sonomotion, Inc. - FDA 510(k) Cleared Devices

Sonomotion, Inc. develops noninvasive platforms for kidney stone treatment. The company specializes in ultrasound-based fragmentation and repositioning technologies designed for office-based procedures on awake patients. Sonomotion operates with a manufacturing facility in San Mateo, California.

The company has received 2 FDA 510(k) clearances from 3 total submissions since 2024. Sonomotion focuses exclusively on Gastroenterology & Urology devices, with its most recent clearance in 2026. The company remains actively engaged in regulatory submissions and product development.

Sonomotion's cleared devices include Break Wave, a lithotripsy system for stone fragmentation using low-pressure ultrasound waves. The platform targets the substantial market of kidney stone disease, which affects over three million Americans annually. The company's technology emphasizes patient comfort and procedural efficiency in clinical office settings.

Explore Sonomotion's device names, product codes, and FDA 510(k) clearance dates in the regulatory database.

1 device has linked clinical trial registered on ClinicalTrials.gov.