# K140458: Diotech Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Diotech CO
- Decided: Aug 26, 2014 after 183 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 K071959 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071959: Angiodynamics, Inc.Nevertouch 600UM Fiber and Venacure Procedure Kit, AngioDynamics, Inc. (2007) Summary page 4.

## Most influential descendants
- K152667: ATOVEN-Reusable Laser Fiber (2016), 0 descendants of its own

## Indications for use
Diotech Laser Fibers (400μm, 600μm) is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity. The Diotech Laser Fibers (400μm, 600μm) may be used with CW laser with wavelength range 810-1470nm, a power range 5-15W, using an SMA905 connector.

Source page: https://510kreport.com/device/K140458
Methodology: https://510kreport.com/methodology