# K140378: Flexguide Ultra Beampath Robotic Fiber Conduit

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Sep 25, 2014 after 223 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K953074 (1995). 33 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray, Omniguide, Inc. (2008) Summary page 4.
- K093251: Omniguide Beampath Fels 25A CO2 Laser System, Omniguide, Inc. (2009) Summary page 5.
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber, Omniguide, Inc. (2007) Summary page 5.
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip, Omniguide, Inc. (2009) Summary page 5.

## Most influential descendants
- K170777: Bovie J-Plasma Precise FLEX Handpiece (2017), 1 descendant of its own
- K202880: J-Plasma Precise FLEX Handpiece (2021), 0 descendants of its own

## Indications for use
The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical specialties: general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.

Source page: https://510kreport.com/device/K140378
Methodology: https://510kreport.com/methodology