ECO2 LASER SYSTEM

Powered Laser Surgical Instrument

LUTRONIC CORPORATION

The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Eco2 Laser System.

Pre-market Notification Details

Device IDK091115
510k NumberK091115
Device Name:ECO2 LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant LUTRONIC CORPORATION 5 TIMBER LANE North Reading,  MA  01864
ContactMaureen O'connell
CorrespondentMaureen O'connell
LUTRONIC CORPORATION 5 TIMBER LANE North Reading,  MA  01864
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-17
Decision Date2009-10-30
Summary:summary

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