UV Biotek Single Panel, UV Biotek Multi-Directional

FDA 510(k) K134009 · Medtek Lighting

Substantially Equivalent

510(k) numberK134009

Submission

Device name
UV Biotek Single Panel, UV Biotek Multi-Directional
Applicant
Medtek Lighting
Coralville, IA, US
Received
December 30, 2013
Decision date
October 15, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTC – Light, Ultraviolet, Dermatological
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4630
Specialty
General, Plastic Surgery

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Questions and answers

When was UV Biotek Single Panel, UV Biotek Multi-Directional cleared by the FDA?

UV Biotek Single Panel, UV Biotek Multi-Directional (K134009) received a 510(k) decision of Substantially Equivalent on October 15, 2014, 289 days after the submission was received.

What is the product code of K134009?

The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.