Cleared Traditional

FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT

K050695 · Daavlin Distributing Co. · General & Plastic Surgery
Apr 2005
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K050695 is an FDA 510(k) clearance for the FLEX CONTROLLED 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 19, 2005, 32 days after receiving the submission on March 18, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.

Submission Details

510(k) Number K050695 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2005
Decision Date April 19, 2005
Days to Decision 32 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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