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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 K101190
Device Name LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
Applicant
Led Intellectual Properties, LLC
9832 Chesterfield Circle
Santa Ana,  CA  92705
Applicant Contact ROBERT T WAGNER
Correspondent
Led Intellectual Properties, LLC
9832 Chesterfield Circle
Santa Ana,  CA  92705
Correspondent Contact ROBERT T WAGNER
Regulation Number878.4810
Classification Product Code
OHS  
Date Received04/28/2010
Decision Date 07/01/2010
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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