510(k) · Cleared
ClearedVeinwave, TC3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newlands Clinical Trials, Ltd. · ONQ Electrosurgical Coagulation For Aesthetic
Cleared on Jun 12, 2009 as substantially equivalent to K061174 (Ellman Int'L, Inc., 2006) and 1 other predicate after a 211-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 211 days
- Class
- Class II
- Product code
- ONQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 1 generation backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- This deviceK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK130283 Evrf SystemF Care Systems NV · 2013
- Descendant · cites it directly · 1 of its ownK210077 MED RF 4000F Care Systems USA, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK252704 F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE…F Care Systems USA, LLC · 2025
- Descendant · cites it directly · 0 of its ownK112334 Vein-Gogh InstrumentRefine USA, LLC · 2012
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 4 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 1 generation backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- This deviceK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K130283Evrf SystemF Care Systems NV · 2013 · cites it directly2descendants
- K210077MED RF 4000F Care Systems USA, LLC · 2021 · cites it directly1descendant
- K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · 2025 · 2 generations on0descendants
- K112334Vein-Gogh InstrumentRefine USA, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −4 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −2 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −1 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| 0 (this device) | K083352 | Veinwave, TC3000 | Newlands Clinical Trials, Ltd. | 2009 | — |
| +1 | K130283 | Evrf System | F Care Systems NV | 2013 | — |
| +1 | K210077 | MED RF 4000 | F Care Systems USA, LLC | 2021 | — |
| +2 | K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB… | F Care Systems USA, LLC | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K061174 | Surgi-MaxSummary page 1…device and Name, Number & accessories Product Code: 878.4400 GEl Predicate Devices: Surgi-Max Electrosurgery Generator- K061174 - Ellman International Inc. Primaeva Medical System - K080145 - Primaeva Medical,… | 2006 |
| * | K080145 | Primaeva Medical SystemSummary page 1…Predicate Devices: Surgi-Max Electrosurgery Generator- K061174 - Ellman International Inc. Primaeva Medical System - K080145 - Primaeva Medical, Inc. Device Description Device Description: The Veinwave/TC3000 system consists… | 2008 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K130283 (F Care Systems NV, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K061174.
How does its category compare?
All ONQ devicesONQ Electrosurgical Coagulation For Aesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Veinwave/TC3000 system is intended for epilation, and 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/K083352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083352: Veinwave, TC3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083352
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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