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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K063152
Device Name CLAROS DENTAL LASER SYSTEM
Applicant
Elexxion AG
Groose Lache 5
Wherheim,  DE 61273
Applicant Contact JOHANNES MUELLER
Correspondent
Elexxion AG
Groose Lache 5
Wherheim,  DE 61273
Correspondent Contact JOHANNES MUELLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/16/2006
Decision Date 03/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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