FDA 510(k)

SoClean 3+

Número K: K243815 · 2025-10-10

Data da decisão2025-10-10

Código do produtoQXQ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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