YOULASER CO2 LASER

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.

Pre-market Notification Details

Device IDK123573
510k NumberK123573
Device Name:YOULASER CO2 LASER
ClassificationPowered Laser Surgical Instrument
Applicant QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona,  IT 21058
ContactMaurizio Bianchi
CorrespondentMaurizio Bianchi
QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona,  IT 21058
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-20
Decision Date2013-04-15
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.