FDA 510(k)

3 Series NeoLux

K-Number: K230382 · 2023-03-24

Decision Date2023-03-24

Product CodeFTC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

3 Series NeoLux is a medical device manufactured by Daavlin Distributing Co.. It received FDA 510(k) clearance on 2023-03-24 under approval number K230382. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3 Series NeoLux?

3 Series NeoLux is a medical device that received FDA 510(k) clearance on 2023-03-24. It is manufactured by Daavlin Distributing Co.. The 510(k) number is K230382.

When was 3 Series NeoLux approved by the FDA?

3 Series NeoLux received FDA 510(k) clearance on 2023-03-24, under approval number K230382.

What company makes 3 Series NeoLux?

3 Series NeoLux is manufactured by Daavlin Distributing Co..

What is the FDA product code for 3 Series NeoLux?

The FDA product code for 3 Series NeoLux is FTC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.