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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 the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) 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. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K230382.

When did 3 Series NeoLux receive FDA 510(k) clearance?

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

Who is the listed applicant for 3 Series NeoLux?

The FDA 510(k) record lists Daavlin Distributing Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Series NeoLux?

The FDA product code for 3 Series NeoLux is FTC.

Other records listing Daavlin Distributing Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.