3 Series NeoLux— 510(k) K230382

Substantially Equivalent

Daavlin Distributing Co.

FDA 510(k) clearance K230382 for 3 Series NeoLux, Substantially Equivalent on 2023-03-24. Applicant: Daavlin Distributing Co.. Device class: 2.

Clearance details

Applicant: Daavlin Distributing Co.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2023-02-13
Decision date: 2023-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Bryan, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.