# K133788: Cook Holmium Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 18, 2015 after 461 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: 3 generations back to K992866 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124030: Cook Holmium Laser Fiber, Cook Incorporated (2013) Summary page 4.

## Indications for use
Used for incision/excision, ablation, and coagulation (hemostasis) when attached to a cleared Ho:YAG laser system comprised of any standard SMA-type connector and an output power of up to 100 watts, for the indications for which the system has been cleared.

Source page: https://510kreport.com/device/K133788
Methodology: https://510kreport.com/methodology