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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 K090744
Device Name CLARO
Applicant
Clrs Technology Corporation
5 Timber Lane
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Clrs Technology Corporation
5 Timber Lane
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/20/2009
Decision Date 04/15/2010
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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