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FDA 510(k)

LUXEN 5G

K-Number: K241151 · 2024-09-30

ApplicantDentalmax Co., Ltd.
Decision Date2024-09-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUXEN 5G is a medical device manufactured by Dentalmax Co., Ltd.. It received FDA 510(k) clearance on 2024-09-30 under approval number K241151. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXEN 5G?

LUXEN 5G is a medical device that received FDA 510(k) clearance on 2024-09-30. It is manufactured by Dentalmax Co., Ltd.. The 510(k) number is K241151.

When was LUXEN 5G approved by the FDA?

LUXEN 5G received FDA 510(k) clearance on 2024-09-30, under approval number K241151.

What company makes LUXEN 5G?

LUXEN 5G is manufactured by Dentalmax Co., Ltd..

What is the FDA product code for LUXEN 5G?

The FDA product code for LUXEN 5G is EIH.

Other Devices by Dentalmax Co., Ltd.

K171585LUXEN Zr, LUXEN Smile K212548LUXEN CL Dental Liquid

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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.

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