# K992472: Sureguide CO2 Laser Beam Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Sep 8, 1999 after 44 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: 2 generations back to K953074 (1995). 3 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943543: Medical Optics CO2 Surgical Laser Systems, Medical Options, Inc. (1994) Summary page 1.
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.

## Most influential descendants
- K014048: Clinicon Universal Waveguide Handpiece and Fiber Tips (2002), 15 descendants of its own
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), 14 descendants of its own
- 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

## Indications for use
The SureGuide CO; Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgety, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue. The specific SureGuide CO, Laser Beam Delivery System indications are dependent upan the cleared indications for use of the laser system and laser system accessories to which it is attached.

Source page: https://510kreport.com/device/K992472
Methodology: https://510kreport.com/methodology