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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 K172413
Device Name MT ONE
Applicant
M&T S.R.L.
Via Pietrarubbia, 32/F
Rimini,  IT
Applicant Contact Fiorenzo Rossi
Correspondent
Endo Engineering S.R.L.
Via Del Consorzio, 41
Falconara Marittima,  IT
Correspondent Contact Chiara Violini
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONF  
Date Received08/10/2017
Decision Date 10/06/2017
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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