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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K142246
Device Name LightStim for Acne/ LightStim for Acne Mini
Applicant
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Applicant Contact Steve Marchese
Correspondent
Led Intellectual Properties, LLC
16552 Von Karman Ave.
Irvine,  CA  92606
Correspondent Contact Steve Marchese
Regulation Number878.4810
Classification Product Code
OLP  
Date Received08/14/2014
Decision Date 01/29/2015
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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