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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 K132833
Device Name ULTRA RENEW PLUS
Applicant
ACCORD MEDIA
1390 ELWOOD DRIVE
LOS GATOS,  CA  95032
Applicant Contact MICHAEL CHIBBARO
Correspondent
ACCORD MEDIA
1390 ELWOOD DRIVE
LOS GATOS,  CA  95032
Correspondent Contact MICHAEL CHIBBARO
Regulation Number878.4810
Classification Product Code
OLP  
Subsequent Product Codes
ISA   OHS  
Date Received09/10/2013
Decision Date 06/17/2014
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
Recalls CDRH Recalls
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