YOULASER CO2 LASER SYSTEM

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 Youlaser Co2 Laser System.

Pre-market Notification Details

Device IDK111592
510k NumberK111592
Device Name:YOULASER CO2 LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona(va),  IT 21058
ContactMaurizio Bianchi
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-06-07
Decision Date2011-08-25
Summary:summary

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