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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 K183118
Device Name dpl SpotLite
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 Received11/09/2018
Decision Date 02/07/2019
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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