Cleared Traditional

K111049 - MOBILE VERSA LIGHT

K111049 is an FDA 510(k) clearance for MOBILE VERSA LIGHT, manufactured by Medtek Lighting Corp. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K111049 · Medtek Lighting Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
406d
Days
Class 2
Risk

K111049 is an FDA 510(k) clearance for the MOBILE VERSA LIGHT. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Medtek Lighting Corp (Knoxville, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medtek Lighting Corp devices

FDA 510(k) Submission Details - K111049

510(k) Number K111049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2011
Decision Date May 25, 2012
Days to Decision 406 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
291d slower than avg
Panel avg: 115d · This submission: 406d
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 78
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K111049.
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
K134009 · Medtek Lighting · Oct 2014
UV PHOTOTHERAPY
K132643 · Xuzhou Kernel Medical Equipment Co., Ltd. · Jan 2014
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
K130519 · Philips Lighting Company · Dec 2013
SMART TOUCH UVTHERAPY MULTIPLE MACHINE
K110912 · Daavlin Distributing Co. · Oct 2011
4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
K111172 · Daavlin Distributing Co. · Aug 2011
ML24000 UVA-1 PHOTOTHERAPY UNIT
K103708 · The Daavlin Distributing Company · Feb 2011