LuxCreo Clear Aligner System
K-Number: K250343 · 2025-04-08
ApplicantLuxCreo, Inc.
Decision Date2025-04-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
LuxCreo Clear Aligner System is a medical device manufactured by LuxCreo, Inc.. It received FDA 510(k) clearance on 2025-04-08 under approval number K250343. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LuxCreo Clear Aligner System?
LuxCreo Clear Aligner System is a medical device that received FDA 510(k) clearance on 2025-04-08. It is manufactured by LuxCreo, Inc.. The 510(k) number is K250343.
When was LuxCreo Clear Aligner System approved by the FDA?
LuxCreo Clear Aligner System received FDA 510(k) clearance on 2025-04-08, under approval number K250343.
What company makes LuxCreo Clear Aligner System?
LuxCreo Clear Aligner System is manufactured by LuxCreo, Inc..
What is the FDA product code for LuxCreo Clear Aligner System?
The FDA product code for LuxCreo Clear Aligner System is NXC.
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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.