# K172325: Rhapsody H-30 Holmium Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 26, 2017 after 86 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 K130444 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130444: H-30 Holmium Laser System, Cook, Inc. (2013) Summary page 4.

## Indications for use
The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.

Source page: https://510kreport.com/device/K172325
Methodology: https://510kreport.com/methodology