# K211761: UltraLase Flexible CO2 Laser Waveguide

- Pathway: 510(k) (Special)
- Applicant: W & R Investments, LLC Dba Laser Engineering
- Decided: Jul 30, 2021 after 52 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: 7 generations back to K953074 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112166: Ultralase Flexible CO2 Laser Waveguide, W and R Investments Dba Laser Engineering (2011) Summary page 4.
- K100384: Fiberlase C02 Laser Waveguide, Lumenis, Ltd. (2010) Summary page 4.

## 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/K211761
Methodology: https://510kreport.com/methodology