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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K090399
Device Name TRIOS SYSTEM
Applicant
Viora , Ltd.
30 Montgomery St.
Suite 660
Jersey City,  NJ  07302
Applicant Contact JOSEF LUZON
Correspondent
Viora , Ltd.
30 Montgomery St.
Suite 660
Jersey City,  NJ  07302
Correspondent Contact JOSEF LUZON
Regulation Number878.4810
Classification Product Code
ONF  
Date Received02/17/2009
Decision Date 06/10/2009
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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