MYDON C

Powered Laser Surgical Instrument

WAVELIGHT LASER TECHNOLOGIE AG

The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Mydon C.

Pre-market Notification Details

Device IDK040384
510k NumberK040384
Device Name:MYDON C
ClassificationPowered Laser Surgical Instrument
Applicant WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading,  MA  01864
ContactMaureen O'connell
CorrespondentMaureen O'connell
WAVELIGHT LASER TECHNOLOGIE AG 5 TIMBER LANE North Reading,  MA  01864
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-17
Decision Date2004-05-14
Summary:summary

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