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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K151841
Device Name Ultraviolet Sunlamps
Applicant
Wolff System Technology Corp.
980 Cobb Pl. Blvd. NW Suite 200
Kennesaw,  GA  30144
Applicant Contact Michael Stepp
Correspondent
Cosmedico Light, Inc.
233 Libbey Indistrial Pkwy.
Weymouth,  MA  01860
Correspondent Contact Steven Schlitt
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/06/2015
Decision Date 10/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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