# K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Feb 1, 2007 after 15 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- 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.
8 later devices descend from it; 4 cite it directly.
0 of 25 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
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), 5 descendants of its own
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (2009), 4 descendants of its own
- 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
- K112166: Ultralase Flexible CO2 Laser Waveguide (2011), 1 descendant of its own

## Recalls of this device
- Nov 5, 2012 · Class II · Z-0453-2013: Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient

## Indications for use
The OmniGuide Mark Ill WaveGuide Fiber is indicated for the 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, 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 laryngoscopy, gastroscopy, colonoscopy, laparoscopy, 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/K070157
Methodology: https://510kreport.com/methodology