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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 K242251
Device Name Litho 60; Litho 100; Litho 150
Applicant
Quanta System Spa
Via Acquedotto 109
Samarate,  IT 21017
Applicant Contact Bandiera Dario
Correspondent
Quanta System Spa
Via Acquedotto 109
Samarate,  IT 21017
Correspondent Contact Bandiera Dario
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/31/2024
Decision Date 09/03/2024
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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