MT One

Powered Laser Surgical Instrument


The following data is part of a premarket notification filed by M&t Srl with the FDA for Mt One.

Pre-market Notification Details

Device IDK192856
510k NumberK192856
Device Name:MT One
ClassificationPowered Laser Surgical Instrument
Applicant M&T SRL Via Pietrarubbia, 32/F Rimini,  IT 47900
ContactFiorenzo Rossi
CorrespondentChiara Violini
Endo Engineering Via Del Consorzio, 41 Falconara Marittaima,  IT 60015
Product CodeGEX  
Subsequent Product CodeONE
Subsequent Product CodeONF
Subsequent Product CodeONG
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-04
Decision Date2020-04-24

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