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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 K162450
Device Name ESPADA Acne-Clearing Blue Light Pen
Applicant
Foreo, Inc.
1525 Pama Lane, Suite 200
Las Vegas,  NV  89119
Applicant Contact Davor Soldo
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4810
Classification Product Code
OLP  
Date Received09/01/2016
Decision Date 11/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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