# K203241: OmniGuide BeamPath OTO-U Fiber

- Pathway: 510(k) (Special)
- Applicant: Omniguide, Inc.
- Decided: Jan 14, 2021 after 72 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip, Omniguide, Inc. (2009) Summary page 4.
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip, Omniguide, Inc. (2008) Summary page 4.

## Indications for use
The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry , dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngology, gastroscopy, colonoscopy, laproscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

Source page: https://510kreport.com/device/K203241
Methodology: https://510kreport.com/methodology