Data / Medical devices / United States / Omni-Guide Holdings, Inc.
Omni-Guide Holdings, Inc.: FDA-registered device maker in Billerica, MA, United States, 26 510(k) clearances
Omni-Guide Holdings, Inc. is registered with the FDA (registration 3005350457) in Billerica, MA, United States. It lists 4 device types. The FDA files 26 510(k) clearances under its listings, the newest dated April 21, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005350457
- Address
- 43 Manning Road, Billerica, MA, United States, 01821
- Owner or operator
- OMNIGUIDE, INC. (9070939)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 9, 2005
- Registered through
- 2026
- Brand names listed
- Beacon Advanced Energy Laser System, BeamPath BP-LE Fiber, BeamPath BP-Robotic Fiber, BeamPath CO2 Laser Fiber Surgical Handpiece, BeamPath ENT-L Fiber, BeamPath GYN-L Fiber, BeamPath NEURO-L Fiber, BeamPath Neuro Handpiece Bayonet and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocautery, Gynecologic (And Accessories) | HGI | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2023 | K230819 | OmniGuide RFID Surgical Laser Fibers | GEX | Substantially Equivalent | Omni-Guide Holdings, Inc. | accessdata.fda.gov |
| April 29, 2022 | K220189 | LISA Laser Surgical Fibers | GEX | Substantially Equivalent | Omni-Guide Holdings, Inc. | accessdata.fda.gov |
| January 14, 2021 | K203241 | OmniGuide BeamPath OTO-U Fiber | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| May 2, 2019 | K183199 | TRIO Handpiece | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| June 28, 2018 | K180993 | Beacon Advanced CO2 Laser System | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| January 2, 2015 | K142229 | Laparoscopic FMsealer | GEI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| September 25, 2014 | K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| July 30, 2014 | K141484 | OPEN FMSEALER | GEI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| May 23, 2014 | K140384 | FMWAND HANDPIECE SE | GEI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| January 3, 2014 | K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | HGI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| February 19, 2013 | K110941 | REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 | GEX | Substantially Equivalent | Allmed Systems, Inc. | accessdata.fda.gov |
| October 18, 2012 | K121881 | DOMAIN SURGICAL SYSTEM | HGI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| July 18, 2011 | K110439 | DOMAIN SURGICAL SYSTEM | GEI | Substantially Equivalent | Domain Surgical, Inc. | accessdata.fda.gov |
| November 20, 2009 | K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| October 29, 2009 | K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| August 12, 2008 | K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| January 2, 2008 | K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| December 14, 2007 | K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| April 17, 2007 | K070466 | REVOLIX DUO LASER SYSTEM | GEX | Substantially Equivalent | Allmed Systems, Inc. | accessdata.fda.gov |
| March 26, 2007 | K070476 | REVOLIX 120 | GEX | Substantially Equivalent | Allmed Systems, Inc. | accessdata.fda.gov |
| February 1, 2007 | K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| November 29, 2006 | K063141 | OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| September 21, 2006 | K062423 | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM | GEX | Substantially Equivalent | Omniguide, Inc. | accessdata.fda.gov |
| May 9, 2005 | K050541 | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY | HQF | Substantially Equivalent | Omniguide Communications, Inc. | accessdata.fda.gov |
| January 20, 2004 | K033437 | SPHINX LASER SYSTEMS | GEX | Substantially Equivalent | Allmed Systems, Inc. | accessdata.fda.gov |
| January 15, 2004 | K033423 | REVOLIX LASER SYSTEMS | GEX | Substantially Equivalent | Allmed Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 24, 2016 | 75627 | Class II | Terminated | FMsealer Open Shears. Model FM3001 | Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage. | accessdata.fda.gov |
| November 5, 2012 | 63642 | Class II | Terminated | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrocautery, Gynecologic (And Accessories)
- All makers of Laser, Ophthalmic
Updated April 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.