OmniGuide, Inc.
FDA Regulatory Profile
OmniGuide, Inc. appears in FDA public data with 1 recall, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0453-2013, Class II) was initiated on November 5, 2012. Its most recent 510(k) clearance was granted on January 14, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0453-2013 | Class II | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is in | November 5, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203241 | OmniGuide BeamPath OTO-U Fiber | January 14, 2021 |
| K183199 | TRIO Handpiece | May 2, 2019 |
| K180993 | Beacon Advanced CO2 Laser System | June 28, 2018 |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | September 25, 2014 |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | November 20, 2009 |
| K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | October 29, 2009 |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | August 12, 2008 |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | January 2, 2008 |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | December 14, 2007 |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | February 1, 2007 |
| K070071 | OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER | January 25, 2007 |
| K063141 | OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER | November 29, 2006 |
| K062423 | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM | September 21, 2006 |
| K061909 | HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 | July 19, 2006 |