# K081939: Omniguide Beampath Fiber Optic Handpiece System and Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Aug 12, 2008 after 35 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: 5 generations back to K844002 (1984). 10 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952006: Accu-Beam Fiber Optic Handpiece, Tti Medical (1995) Summary page 1.
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) 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
- K183199: TRIO Handpiece (2019), 0 descendants of its own

## Indications for use
The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology.

Source page: https://510kreport.com/device/K081939
Methodology: https://510kreport.com/methodology