Cleared Traditional

M Series Phototherapy Equipment

K210881 · Daavlin Distributing Co. · General & Plastic Surgery
Jun 2021
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K210881 is an FDA 510(k) clearance for the M 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 June 22, 2021, 89 days after receiving the submission on March 25, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.

Submission Details

510(k) Number K210881 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2021
Decision Date June 22, 2021
Days to Decision 89 days
Submission Type Traditional
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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