# K251303: Tamburo Thulium Fiber Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Menovex Medical Technology (Shenzhen) Co., Ltd.
- Decided: Nov 4, 2025 after 190 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: 9 generations back to K936109 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 5.

## Indications for use
The Tamburo Thulium Fiber Laser System are 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/K251303
Methodology: https://510kreport.com/methodology