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FDA 510(k)

Stone Clear (BWSC-LP9-02)

K-Number: K262200 · 2026-07-29

ApplicantSonomotion, Inc.
Decision Date2026-07-29
Product CodeQNA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Stone Clear (BWSC-LP9-02) is the device name listed in this FDA 510(k) record. The listed applicant is Sonomotion, Inc.. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K262200. The device is classified under product code QNA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stone Clear (BWSC-LP9-02)?

Stone Clear (BWSC-LP9-02) is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Sonomotion, Inc.. The 510(k) number is K262200.

When did Stone Clear (BWSC-LP9-02) receive FDA 510(k) clearance?

Stone Clear (BWSC-LP9-02) received FDA 510(k) clearance on 2026-07-29, under 510(k) number K262200.

Who is the listed applicant for Stone Clear (BWSC-LP9-02)?

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 Stone Clear (BWSC-LP9-02)?

The FDA product code for Stone Clear (BWSC-LP9-02) is QNA.

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.

K261086Break WaveK252913Break Wave

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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