# K112334: Vein-Gogh Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Refine USA, LLC
- Decided: May 8, 2012 after 270 days
- Product code: ONQ (Electrosurgical Coagulation For Aesthetic)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083352: Veinwave, TC3000, Newlands Clinical Trials, Ltd. (2009) Summary page 3.

## Indications for use
The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation..

Source page: https://510kreport.com/device/K112334
Methodology: https://510kreport.com/methodology