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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 K110984
Device Name SLIM E30 II CO2 LASER
Applicant
Lasering S.R.L.
2246 Camino Ramon
San Ramon,  CA  94583
Applicant Contact ALLEN R HOWES
Correspondent
Lasering S.R.L.
2246 Camino Ramon
San Ramon,  CA  94583
Correspondent Contact ALLEN R HOWES
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received04/07/2011
Decision Date 07/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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