# K152667: ATOVEN-Reusable Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Diotech CO
- Decided: Jun 9, 2016 after 266 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: 4 generations back to K904627 (1991). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140458: Diotech Laser Fiber, Diotech CO (2014) Summary page 4.
- K140366: Endlessfiber Reusable Surgical Laser Fiber, Hogue Surgical, LLC (2014) Summary page 4.

## Indications for use
ATOVEN-Reusable Laser Fiber 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 ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 nm, a power range 5-15W, using an SMA905 connector.

Source page: https://510kreport.com/device/K152667
Methodology: https://510kreport.com/methodology