Opera Evo

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 Opera Evo.

Pre-market Notification Details

Device IDK202041
510k NumberK202041
Device Name:Opera Evo
ClassificationPowered Laser Surgical Instrument
Applicant Quanta System SpA Via Acquedotto 109 Samarate,  IT 21017
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
Quanta System SpA Via Acquedotto 109 Samarate,  IT 21017
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-23
Decision Date2020-10-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08059173390700 K202041 000

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