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 a medical device manufactured by Soclean, Inc.. It received FDA 510(k) clearance on 2025-10-10 under approval 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. It is manufactured by Soclean, Inc.. The 510(k) number is K243815.
When was SoClean 3+ approved by the FDA?
SoClean 3+ received FDA 510(k) clearance on 2025-10-10, under approval number K243815.
What company makes SoClean 3+?
SoClean 3+ is manufactured by Soclean, Inc..
What is the FDA product code for SoClean 3+?
The FDA product code for SoClean 3+ is QXQ.
Other Devices by Soclean, Inc.
Related Devices (Code: QXQ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.