510(k) · Cleared
ClearedVein-Gogh Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Refine USA, LLC · ONQ Electrosurgical Coagulation For Aesthetic
Cleared on May 8, 2012 as substantially equivalent to K083352 (Newlands Clinical Trials, Ltd., 2009) after a 270-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- May 8, 2012
- Review
- 270 days
- Class
- Class II
- Product code
- ONQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K943450 (1995). 27 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 2 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 1 generation backK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
- This deviceK112334 Vein-Gogh InstrumentRefine USA, LLC · 2012
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 5 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 4 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 3 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 2 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 1 generation backK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
- This deviceK112334 Vein-Gogh InstrumentRefine USA, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −5 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −4 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −3 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −2 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −1 | K083352 | Veinwave, TC3000 | Newlands Clinical Trials, Ltd. | 2009 | — |
| 0 (this device) | K112334 | Vein-Gogh Instrument | Refine USA, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ONQ device
- #1 K210077 MED RF 4000score 8.5 · 11 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083352 | Veinwave, TC3000Summary page 3…bstantially equivalent to the presently marketed Veinwave/TC3000 device manufactured by Newlands Clinical Trials, Ltd., Bolton, United Kingdom, and cleared under K083352. DEVICE DESCRIPTION - as required by 807.92(a)(4) The VeinGogh instrument is intended for the treatment of lower l… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083352.
How does its category compare?
All ONQ devicesONQ Electrosurgical Coagulation For Aesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ONQ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · ONQ
Too few ONQ 510(k)s in any year since 2007 to give a median.
Recalls per year · ONQ
No recall names ONQ since 2007.
Adverse event reports per year · ONQ
1in 2013
MAUDE reports naming product code ONQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VeinGogh device is intended for the treatment of lower limb
spider vein or telangiectasia by thermocoagulation..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112334: Vein-Gogh Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112334
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026