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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 K083613
Device Name QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
Applicant
Quanta System Spa
Via Iv Novembre, 116
Solbiate Olona (Va),  IT 21058
Applicant Contact ISABELLA CARRER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/08/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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