# K093251: Omniguide Beampath Fels 25A CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Oct 29, 2009 after 13 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: 2 generations back to K875338 (1988). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063698: CO2 Laser System, Model C-Las, Clinicon Corp. (2007) Summary page 1.

## Most influential descendants
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (2014), 2 descendants of its own
- 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 BeamPath FELS 25A, CO 2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties: Dermatology General Surgery Gynecology Head & Neck Surgery Neurosurgery Oral Surgery Orthopedic Surgery Otorhinolaryngology Pediatric Surgery Plastic & Reconstructive Surgery Podiatry Urology

Source page: https://510kreport.com/device/K093251
Methodology: https://510kreport.com/methodology