Cleared Special

3 Series NeoLux

K230382 · Daavlin Distributing Co. · General & Plastic Surgery
Mar 2023
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K230382 is an FDA 510(k) clearance for the 3 Series NeoLux, a Light, Ultraviolet, Dermatological (Class II — Special Controls, product code FTC), submitted by Daavlin Distributing Co. (Bryan, US). The FDA issued a Cleared decision on March 24, 2023, 39 days after receiving the submission on February 13, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.

Submission Details

510(k) Number K230382 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2023
Decision Date March 24, 2023
Days to Decision 39 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTC — Light, Ultraviolet, Dermatological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4630

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