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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 K180447
Device Name reVive Light Therapy LED Cleansing System
Applicant
Led Technologies, Inc.
6000 Greenwood Plz. Blvd., Suite 110
Greenwood Village,  CO  80111
Applicant Contact Lloyd Nelson
Correspondent
Led Technologies, Inc.
6000 Greenwood Plz. Blvd., Suite 110
Greenwood Village,  CO  80111
Correspondent Contact Jelena Barbaric
Regulation Number878.4810
Classification Product Code
OLP  
Date Received02/20/2018
Decision Date 06/04/2018
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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