# K061909: Highland Beam Delivery System, Model 3-099-002-00-00

- Pathway: 510(k) (Traditional)
- Applicant: Omniguide, Inc.
- Decided: Jul 19, 2006 after 13 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.
2 later devices descend from it; 1 cites it directly.
0 of 19 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.
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery, Omniguide Communications, Inc. (2005) Summary page 1.

## Most influential descendants
- K063141: Omniguide Zero Flow ZF-T 150 Waveguide Fiber (2006), 1 descendant of its own
- K070071: Omniguide Zero Flow ZF-T Waveguide Fiber (2007), 0 descendants of its own

## Indications for use
The OmniGuide's Highland Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraorat tissues, in the medical specialties of general and plastic surgery, oral / maxittofaciat surgery, dentistry, dermatology, endoscopic surgical procedures related to gynecology, otorhinotaryngotogy, neurosurgery, gastroenterology, and pulmonary surgery for surgical and aesthetic applications. The indications for use for which the device is used are also dependant upon the cleared indications for use of the laser system and the laser system accessories to which it is attached.

Source page: https://510kreport.com/device/K061909
Methodology: https://510kreport.com/methodology