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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K141181
Device Name NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
Applicant
Led Technologies, LLC
2424 Dempster Dr.
Coralville,  IA  52241
Applicant Contact SUSAN ANTHONEY-DEWET
Correspondent
Led Technologies, LLC
2424 Dempster Dr.
Coralville,  IA  52241
Correspondent Contact SUSAN ANTHONEY-DEWET
Regulation Number878.4810
Classification Product Code
OHS  
Date Received05/07/2014
Decision Date 03/31/2015
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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