Cleared Special

ML24000 UVA-1 Phototherapy Cabinet

K151795 · Daavlin Distributing Co. · General & Plastic Surgery
Sep 2015
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K151795 is an FDA 510(k) clearance for the ML24000 UVA-1 Phototherapy Cabinet, 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 September 10, 2015, 70 days after receiving the submission on July 2, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.

Submission Details

510(k) Number K151795 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2015
Decision Date September 10, 2015
Days to Decision 70 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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