Medical Device Manufacturer · US , Cambridge , MA

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

14 submissions · 14 cleared · Since 2006

Recent clearances: OmniGuide BeamPath OTO-U Fiber, TRIO Handpiece, Beacon Advanced CO2 Laser System

14
Total
14
Cleared
0
Denied

Omniguide, Inc. has 14 FDA 510(k) cleared general & plastic surgery devices. Based in Cambridge, US.

Last cleared in 2021. Active since 2006.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Omniguide, Inc.

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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