# K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide Communications, Inc.
- Decided: May 9, 2005 after 68 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953074 (1995). 15 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992472: Sureguide CO2 Laser Beam Delivery System, Clinicon Corp. (1999) Summary page 1.
- K014048: Clinicon Universal Waveguide Handpiece and Fiber Tips, Clinicon Corp. (2002) Summary page 1.
- K924664: Surgilase Fiberlase CO2 Laser Waveguide, Surgilase, Inc. (1993) Summary page 1.
- K921671: Surgilase Fiberlase VCO2 Laser Waveguide, Surgical Products Corp. (1992) Summary page 1.
- K896478: Luxar Model LX-20 Minilase CO2 Laser, Luxar Corp. (1990) Summary page 1.
- K031440: Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser, Cynosure, Inc. (2003) Summary page 1.
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories, Erbe USA, Inc. (1996) Summary page 1.
- K032969: Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe, Helica Instruments, Ltd. (2004) Summary page 1.

## Most influential descendants
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber (2007), 8 descendants of its own
- 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
- K061909: Highland Beam Delivery System, Model 3-099-002-00-00 (2006), 2 descendants of its own

## Indications for use
The OmniGuide BeamPath C02 Mark I Laser 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 for which the delivery system is used 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/K050541
Methodology: https://510kreport.com/methodology