# K112166: Ultralase Flexible CO2 Laser Waveguide

- Pathway: 510(k) (Traditional)
- Applicant: W and R Investments Dba Laser Engineering
- Decided: Oct 21, 2011 after 85 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: 6 generations back to K953074 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100384: Fiberlase C02 Laser Waveguide, Lumenis, Ltd. (2010) Summary page 1.
- K992472: Sureguide CO2 Laser Beam Delivery System, Clinicon Corp. (1999) Summary page 1.
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber, Omniguide, Inc. (2007) Summary page 1.

## Most influential descendants
- K211761: UltraLase Flexible CO2 Laser Waveguide (2021), 0 descendants of its own

## Indications for use
The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues. The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

Source page: https://510kreport.com/device/K112166
Methodology: https://510kreport.com/methodology