Break Wave

FDA 510(k) K261086 · Sonomotion, Inc.

Substantially Equivalent

510(k) numberK261086

Submission

Device name
Break Wave
Applicant
Sonomotion, Inc.
San Mateo, CA, US
Received
April 1, 2026
Decision date
April 29, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K252913Break WaveLNS · Traditional Sonomotion, Inc.01/12/2026SE
K242922Extracorporeal Shock Wave Lithotripter (U200)LNS · Traditional Shenzhen Wikkon Precision Technologies Co., Ltd.06/18/2025SE
K221903Delta III ProLNS · Traditional Dornier Medtech America, Inc.02/22/2023SE
K213772LM-9300 Plus LithotripterLNS · Traditional Lite-Med, Inc.01/19/2023SE
K201001Modulith SLX-F2LNS · Traditional Karl Storz Endoscopy America03/30/2021SE
K201074Delta III LithotripterLNS · Traditional Dornier Medtech America, Inc.09/03/2020SE
K172084Delta III LithotripterLNS · Special Dornier Medtech America, Inc.08/08/2017SE
K170122Delta III LithotripterLNS · Traditional Dornier Medtech America06/28/2017SE
K151298Gemini XXP-HPLNS · Traditional Dornier Medtech America07/30/2015SE
K142561LM-9300 ELMA LithotripterLNS · Abbreviated Lite-Med, Inc.03/20/2015SE

More from Lite-Med, Inc.

510(k)DeviceDecision
K262200Stone Clear (BWSC-LP9-02)QNA · Special 07/29/2026SE
K252913Break WaveLNS · Traditional 01/12/2026SE

Questions and answers

When was Break Wave cleared by the FDA?

Break Wave (K261086) received a 510(k) decision of Substantially Equivalent on April 29, 2026, 28 days after the submission was received.

What is the product code of K261086?

The FDA product code is LNS – Lithotriptor, Extracorporeal Shock-Wave, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5990.