Cleared Special

K220840 - 1 Series Phototherapy Equipment
(FDA 510(k) Clearance)

K220840 · Daavlin Distributing Co. · General & Plastic Surgery
Apr 2022
Decision
30d
Days
Class 2
Risk

K220840 is an FDA 510(k) clearance for the 1 Series Phototherapy Equipment, 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 April 22, 2022, 30 days after receiving the submission on March 23, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.

Submission Details

510(k) Number K220840 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2022
Decision Date April 22, 2022
Days to Decision 30 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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