OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM

Powered Laser Surgical Instrument

OMNIGUIDE, INC.

The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beampath Fels 25a Co2 Laser System.

Pre-market Notification Details

Device IDK093251
510k NumberK093251
Device Name:OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant OMNIGUIDE, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge,  MA  02139
ContactDouglas W Woodruff
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 Received2009-10-16
Decision Date2009-10-29
Summary:summary

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