# K130164: Fiberlase Endure CO2 Fiber

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Mar 24, 2013 after 60 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921671 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 2.

## Recalls of this device
- Jul 22, 2025 · Class II · Z-2344-2025: The potential for unsterilized product within finished product labeled as sterile.

## Indications for use
The FiberLose Endure C02 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. FiberLose Endure C02 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.

Source page: https://510kreport.com/device/K130164
Methodology: https://510kreport.com/methodology