# K124030: Cook Holmium Laser Fiber

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 1, 2013 after 185 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 K992866 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073496: Optilite Holmium Laser Fibers, Cook Urological, Inc. (2008) Summary page 1.

## Most influential descendants
- K163197: Cook Holmium Laser Fiber (2017), 0 descendants of its own
- K133788: Cook Holmium Laser Fiber (2015), 0 descendants of its own

## Recalls of this device
- May 9, 2017 · Class II · Z-2539-2017: Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these p

## Indications for use
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-3D Holmium Laser System for the indications for which the system has been cleared.

Source page: https://510kreport.com/device/K124030
Methodology: https://510kreport.com/methodology