Thunder, Thunder VT, Thunder HR

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 Thunder, Thunder Vt, Thunder Hr.

Pre-market Notification Details

Device IDK171711
510k NumberK171711
Device Name:Thunder, Thunder VT, Thunder HR
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-09
Decision Date2017-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08033945936983 K171711 000
08033945936976 K171711 000
08033945936969 K171711 000
08033945936952 K171711 000

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