OmniGuide, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0453-2013Class IIOmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is inNovember 5, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K203241OmniGuide BeamPath OTO-U FiberJanuary 14, 2021
K183199TRIO HandpieceMay 2, 2019
K180993Beacon Advanced CO2 Laser SystemJune 28, 2018
K140378FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUITSeptember 25, 2014
K093451OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIPNovember 20, 2009
K093251OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEMOctober 29, 2009
K081939OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAYAugust 12, 2008
K073313MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIPJanuary 2, 2008
K073409OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEMDecember 14, 2007
K070157OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBERFebruary 1, 2007
K070071OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBERJanuary 25, 2007
K063141OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBERNovember 29, 2006
K062423OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEMSeptember 21, 2006
K061909HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00July 19, 2006