OPTILITE HOLMIUM LASER FIBERS

Powered Laser Surgical Instrument

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Optilite Holmium Laser Fibers.

Pre-market Notification Details

Device IDK073496
510k NumberK073496
Device Name:OPTILITE HOLMIUM LASER FIBERS
ClassificationPowered Laser Surgical Instrument
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
ContactCindy Foote
CorrespondentCindy Foote
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer,  IN  47460
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-12
Decision Date2008-01-23
Summary:summary

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