FDA 510(k) Applications Submitted by OMNIGUIDE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K203241 |
11/03/2020 |
OmniGuide BeamPath OTO-U Fiber |
OmniGuide, Inc. |
| K070071 |
01/08/2007 |
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
| K070157 |
01/17/2007 |
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
| K081939 |
07/08/2008 |
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY |
OMNIGUIDE, INC. |
| K062423 |
08/18/2006 |
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM |
OMNIGUIDE, INC. |
| K063141 |
10/16/2006 |
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
| K093251 |
10/16/2009 |
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM |
OMNIGUIDE, INC. |
| K093451 |
11/05/2009 |
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP |
OMNIGUIDE, INC. |
| K073313 |
11/26/2007 |
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP |
OMNIGUIDE, INC. |
| K073409 |
12/04/2007 |
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM |
OMNIGUIDE, INC. |
| K061909 |
07/06/2006 |
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 |
OMNIGUIDE, INC. |
| K140378 |
02/14/2014 |
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT |
OMNIGUIDE, INC. |
| K183199 |
11/19/2018 |
TRIO Handpiece |
OmniGuide, Inc. |
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