Fiber Dust

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 Fiber Dust.

Pre-market Notification Details

Device IDK210142
510k NumberK210142
Device Name:Fiber Dust
ClassificationPowered Laser Surgical Instrument
Applicant Quanta System Spa via Acquedotto 109 Samarate (va),  IT 21017
ContactFrancesco Dell'antonio
CorrespondentFrancesco Dell'antonio
Quanta System Spa via Acquedotto 109 Samarate (va),  IT 21017
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-03-11

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