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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 K152714
Device Name Quanta Forte
Applicant
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Applicant Contact FRANCESCO DELL'ANTONIO
Correspondent
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Correspondent Contact FRANCESCO DELL'ANTONIO
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received09/21/2015
Decision Date 12/21/2015
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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