Cleared Traditional

K134009 - UV BIOTEK SINGLE PANEL

K134009 is an FDA 510(k) clearance for UV BIOTEK SINGLE PANEL, manufactured by Medtek Lighting. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K134009 · Medtek Lighting · General & Plastic Surgery device
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Oct 2014
Decision
289d
Days
Class 2
Risk

K134009 is an FDA 510(k) clearance for the UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Medtek Lighting (Coralville, US). The FDA issued a Cleared decision on October 15, 2014 after a review of 289 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtek Lighting devices

FDA 510(k) Submission Details - K134009

510(k) Number K134009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date October 15, 2014
Days to Decision 289 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 115d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 52
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