MOBILE VERSA LIGHT

Light, Ultraviolet, Dermatological

MEDTEK LIGHTING CORP

The following data is part of a premarket notification filed by Medtek Lighting Corp with the FDA for Mobile Versa Light.

Pre-market Notification Details

Device IDK111049
510k NumberK111049
Device Name:MOBILE VERSA LIGHT
ClassificationLight, Ultraviolet, Dermatological
Applicant MEDTEK LIGHTING CORP 1131 ANTHEM VIEW LANE Knoxville,  TN  37922
ContactRobert Wagner
CorrespondentRobert Wagner
MEDTEK LIGHTING CORP 1131 ANTHEM VIEW LANE Knoxville,  TN  37922
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-15
Decision Date2012-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B343VL1400 K111049 000
B343ML600 K111049 000

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