# K062423: Omniguide Beampath Laser Beam Delivery System

- Pathway: 510(k) (Special)
- Applicant: Omniguide, Inc.
- Decided: Sep 21, 2006 after 34 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 K953074 (1995). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery, Omniguide Communications, Inc. (2005) Summary page 1.

## Most influential descendants
- K073409: Omniguide Sterile Waveguide Adapter System (2007), 0 descendants of its own

## Indications for use
The OmniGuide Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology otorhinolaryngology, gastroenterology, neurosurgery pulmonary surgery for surgical and aesthetic applications. The indications for use which the delivery system is used are dependant 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/K062423
Methodology: https://510kreport.com/methodology