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FDA 510(k)

Break Wave

K-Number: K261086 · 2026-04-29

ApplicantSonomotion, Inc.
Decision Date2026-04-29
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Break Wave is the device name listed in this FDA 510(k) record. The listed applicant is Sonomotion, Inc.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K261086. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Break Wave?

Break Wave is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Sonomotion, Inc.. The 510(k) number is K261086.

When did Break Wave receive FDA 510(k) clearance?

Break Wave received FDA 510(k) clearance on 2026-04-29, under 510(k) number K261086.

Who is the listed applicant for Break Wave?

The FDA 510(k) record lists Sonomotion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Break Wave?

The FDA product code for Break Wave is LNS.

Other records listing Sonomotion, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262200Stone Clear (BWSC-LP9-02)K252913Break Wave

Related Devices (Code: LNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy AmericaK201074Delta III LithotripterDornier Medtech America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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