Empower H65

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 Empower H65.

Pre-market Notification Details

Device IDK180423
510k NumberK180423
Device Name:Empower H65
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-16
Decision Date2018-03-15
Summary:summary

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