# K250113: neoLaser Laser Surgery Fibers

- Pathway: 510(k) (Traditional)
- Applicant: G.N.S Neolaser, Ltd.
- Decided: Mar 13, 2025 after 56 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: 25 generations back to K943450 (1995). 403 ancestors in all.
No later device cites it as a predicate yet.
0 of 404 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232769: BeaMed Laser Surgery Fibers, Bt Beamedical Tachnoogies Ltd. (Beamed) (2023) Summary page 5.

## Indications for use
The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

Source page: https://510kreport.com/device/K250113
Methodology: https://510kreport.com/methodology