EVO Platform

Powered Laser Surgical Instrument

Quanta System SpA

The following data is part of a premarket notification filed by Quanta System Spa with the FDA for Evo Platform.

Pre-market Notification Details

Device IDK152012
510k NumberK152012
Device Name:EVO Platform
ClassificationPowered Laser Surgical Instrument
Applicant Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va),  IT 21058
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
Quanta System SpA Via IV Novembre, 116 Solbiate Olona (va),  IT 21058
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-21
Decision Date2015-12-08
Summary:summary

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