LuMon(TM) System
K-Number: K243765 · 2025-08-07
ApplicantSentec AG
Decision Date2025-08-07
Product CodeQEB
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
LuMon(TM) System is a medical device manufactured by Sentec AG. It received FDA 510(k) clearance on 2025-08-07 under approval number K243765. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LuMon(TM) System?
LuMon(TM) System is a medical device that received FDA 510(k) clearance on 2025-08-07. It is manufactured by Sentec AG. The 510(k) number is K243765.
When was LuMon(TM) System approved by the FDA?
LuMon(TM) System received FDA 510(k) clearance on 2025-08-07, under approval number K243765.
What company makes LuMon(TM) System?
LuMon(TM) System is manufactured by Sentec AG.
What is the FDA product code for LuMon(TM) System?
The FDA product code for LuMon(TM) System is QEB.
Other Devices by Sentec AG
Related Devices (Code: QEB)
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.