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FDA 510(k)

SoClean 3+

K-Number: K243815 · 2025-10-10

ApplicantSoclean, Inc.
Decision Date2025-10-10
Product CodeQXQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SoClean 3+ is the device name listed in this FDA 510(k) record. The listed applicant is Soclean, Inc.. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K243815. The device is classified under product code QXQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoClean 3+?

SoClean 3+ is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Soclean, Inc.. The 510(k) number is K243815.

When did SoClean 3+ receive FDA 510(k) clearance?

SoClean 3+ received FDA 510(k) clearance on 2025-10-10, under 510(k) number K243815.

Who is the listed applicant for SoClean 3+?

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

What is the FDA product code for SoClean 3+?

The FDA product code for SoClean 3+ is QXQ.

Related Devices (Code: QXQ)

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.

K252471Paptizer 360LiViliti Health Products Corporation

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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