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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 K183247
Device Name dpl Faceware
Applicant
Led Technologies, Inc.
6000 Greenwood Plaza Blvd., Suite 110
Greenwood Village,  CO  80111
Applicant Contact Lloyd Nelson
Correspondent
Led Technologies, Inc.
6000 Greenwood Plaza Blvd., Suite 110
Greenwood Village,  CO  80111
Correspondent Contact Jelena Barbaric
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received11/21/2018
Decision Date 03/14/2019
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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