Discovery Pico, Discovery Pico Plus

Powered Laser Surgical Instrument

Quanta System S.p.A.

The following data is part of a premarket notification filed by Quanta System S.p.a. with the FDA for Discovery Pico, Discovery Pico Plus.

Pre-market Notification Details

Device IDK171945
510k NumberK171945
Device Name:Discovery Pico, Discovery Pico Plus
ClassificationPowered Laser Surgical Instrument
Applicant Quanta System S.p.A. Via Acquedotto, 109 Samarate,  IT 20826
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
Quanta System S.p.A. Via Acquedotto, 109 Samarate,  IT 20826
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-28
Decision Date2017-07-28
Summary:summary

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