# K100384: Fiberlase C02 Laser Waveguide

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Apr 12, 2010 after 55 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: 1 generation back to K921671 (1992). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921671: Surgilase Fiberlase VCO2 Laser Waveguide, Surgical Products Corp. (1992) Summary page 1.

## Most influential descendants
- K203799: ProFlex CO2 Laser Fiber (2021), 1 descendant of its own
- K112166: Ultralase Flexible CO2 Laser Waveguide (2011), 1 descendant of its own
- K243588: Single Use CO2 Laser Fiber (HAF005001) (2025), 0 descendants of its own
- K211761: UltraLase Flexible CO2 Laser Waveguide (2021), 0 descendants of its own
- K130164: Fiberlase Endure CO2 Fiber (2013), 0 descendants of its own

## Indications for use
The FiberLase C02 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase C02 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endloscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.

Source page: https://510kreport.com/device/K100384
Methodology: https://510kreport.com/methodology