Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60

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 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60.

Pre-market Notification Details

Device IDK192600
510k NumberK192600
Device Name:Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
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 Received2019-09-20
Decision Date2020-02-21

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