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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 With Microbeam\Fractional Output
510(k) Number K100610
Device Name LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
Applicant
Lutronic Corporation
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Lutronic Corporation
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received03/03/2010
Decision Date 01/20/2011
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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