# K083352: Veinwave, TC3000

- Pathway: 510(k) (Traditional)
- Applicant: Newlands Clinical Trials, Ltd.
- Decided: Jun 12, 2009 after 211 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: 9 generations back to K943450 (1995). 26 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061174: Surgi-Max, Ellman Int'L, Inc. (2006) Summary page 1.
- K080145: Primaeva Medical System, Primaeva Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K130283: Evrf System (2013), 2 descendants of its own
- K210077: MED RF 4000 (2021), 1 descendant of its own
- K252704: F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) (2025), 0 descendants of its own
- K112334: Vein-Gogh Instrument (2012), 0 descendants of its own

## Indications for use
The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

Source page: https://510kreport.com/device/K083352
Methodology: https://510kreport.com/methodology