Ultraviolet Sunlamps

Booth, Sun Tan

Wolff System Technology Corp.

The following data is part of a premarket notification filed by Wolff System Technology Corp. with the FDA for Ultraviolet Sunlamps.

Pre-market Notification Details

Device IDK151841
510k NumberK151841
Device Name:Ultraviolet Sunlamps
ClassificationBooth, Sun Tan
Applicant Wolff System Technology Corp. 980 Cobb Place Blvd N.W. Suite 200 Kennesaw,  GA  30144
ContactMichael Stepp
CorrespondentSteven Schlitt
Cosmedico Light, Inc. 233 Libbey Indistrial Pkwy Weymouth,  MA  01860
Product CodeLEJ  
CFR Regulation Number878.4635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-06
Decision Date2015-10-05
Summary:summary

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