Medical Device Manufacturer · US , Cambridge , MA

Omniguide, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2006
14
Total
14
Cleared
0
Denied

FDA 510(k) cleared devices by Omniguide, Inc. General & Plastic Surgery

14 devices
1-14 of 14
Cleared Jan 14, 2021
OmniGuide BeamPath OTO-U Fiber
K203241 · GEX
General & Plastic Surgery · 72d
Cleared May 02, 2019
TRIO Handpiece
K183199 · GEX
General & Plastic Surgery · 164d
Cleared Jun 28, 2018
Beacon Advanced CO2 Laser System
K180993 · GEX
General & Plastic Surgery · 73d
Cleared Sep 25, 2014
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
K140378 · GEX
General & Plastic Surgery · 223d
Cleared Nov 20, 2009
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
K093451 · GEX
General & Plastic Surgery · 15d
Cleared Oct 29, 2009
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
K093251 · GEX
General & Plastic Surgery · 13d
Cleared Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939 · GEX
General & Plastic Surgery · 35d
Cleared Jan 02, 2008
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
K073313 · GEX
General & Plastic Surgery · 37d
Cleared Dec 14, 2007
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
K073409 · GEX
General & Plastic Surgery · 10d
Cleared Feb 01, 2007
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
K070157 · GEX
General & Plastic Surgery · 15d
Cleared Jan 25, 2007
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
K070071 · GEX
General & Plastic Surgery · 17d
Cleared Nov 29, 2006
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
K063141 · GEX
General & Plastic Surgery · 44d
Cleared Sep 21, 2006
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
K062423 · GEX
General & Plastic Surgery · 34d
Cleared Jul 19, 2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
K061909 · GEX
General & Plastic Surgery · 13d
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