# K080525: Cook Odyssey Holmium Laser System, Model 30W

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Apr 17, 2008 after 51 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 K936109 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 1.
- K061455: Dornier Medilas H 20 Laser, Dornier Medtech America, Inc. (2006) Summary page 1.
- K951910: Odyssey HO:Yag Surgical Laser Systems & Accessories, Xintec Corporation (1995) Summary page 1.

## Indications for use
Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.

Source page: https://510kreport.com/device/K080525
Methodology: https://510kreport.com/methodology