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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 K223404
Device Name Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Applicant
Quanta System, S.p.A.
Via Acquedotto 109
Samarate,  IT 21017
Applicant Contact Dario Bandiera
Correspondent
Quanta System, S.p.A.
Via Acquedotto 109
Samarate,  IT 21017
Correspondent Contact Dario Bandiera
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/09/2022
Decision Date 01/20/2023
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
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