# K242293: Medical Thulium Fiber Laser Systems (UroFiber 60Q)

- Pathway: 510(k) (Traditional)
- Applicant: Rhein Laser Technologies Co., Ltd.
- Decided: Nov 19, 2024 after 109 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 K210142 (2021). 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)
- K210142: Fiber Dust, Quanta System Spa (2021) Summary page 5.

## Indications for use
Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Source page: https://510kreport.com/device/K242293
Methodology: https://510kreport.com/methodology