# K261738: Medical Thulium Fiber Laser Systems (UroFiber 150Q)

- Pathway: 510(k) (Traditional)
- Applicant: Rhein Laser Technologies Co., Ltd.
- Decided: Jul 21, 2026 after 55 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: 22 generations back to K943450 (1995). 341 ancestors in all.
No later device cites it as a predicate yet.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253100: MultiPulse TFL, Asclepion Laser Technologies GmbH (2025) Summary page 5.
- K133891: Multipulse TM+1470, Asclepion Laser Technologies GmbH (2015) Summary page 5.

## Indications for use
Medical Thulium Fiber Laser Systems (UroFiber 150Q) is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Source page: https://510kreport.com/device/K261738
Methodology: https://510kreport.com/methodology