510(k) · Cleared
ClearedMED RF 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
F Care Systems USA, LLC · ONQ Electrosurgical Coagulation For Aesthetic
Cleared on Dec 17, 2021 as substantially equivalent to K130283 (F Care Systems NV, 2013) and 1 other predicate after a 339-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- Dec 17, 2021
- Review
- 339 days
- Class
- Class II
- Product code
- ONQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 2 generations backK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
- 1 generation backK130283 Evrf SystemF Care Systems NV · 2013
- This deviceK210077 MED RF 4000F Care Systems USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK252704 F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE…F Care Systems USA, LLC · 2025
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 6 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 5 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 4 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 3 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 2 generations backK083352 Veinwave, TC3000Newlands Clinical Trials, Ltd. · 2009
- 1 generation backK130283 Evrf SystemF Care Systems NV · 2013
- This deviceK210077 MED RF 4000F Care Systems USA, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −6 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −5 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −4 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −3 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −2 | K083352 | Veinwave, TC3000 | Newlands Clinical Trials, Ltd. | 2009 | — |
| −1 | K130283 | Evrf System | F Care Systems NV | 2013 | — |
| 0 (this device) | K210077 | MED RF 4000 | F Care Systems USA, LLC | 2021 | — |
| +1 | K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB… | F Care Systems USA, LLC | 2025 | — |
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 |
|---|---|---|
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K130283 | Evrf SystemSummary page 4…8.4400 Predicate Device Company Product 510(k)# FCare Systems NV EVRF K130283 K210077 Page 2/5 Indications for Use… | 2013 |
| * | K083352 | Veinwave, TC3000Summary page 7…FCARE SYSTEMS Med RF 4000 EVRF 510(k) Number K210077 K083352 Classification and 878.4400 878.4400 Product Code Product Code ON… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | 2025 | 0 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K252704 (F Care Systems USA, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ONQ devicesONQ Electrosurgical Coagulation For Aesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 MED RF 4000 SYSTEM IS INTENDED FOR THE EPILATION AND FOR THE TREATMENT OF LOWER LIMB SPIDER VEIN OR TELANGECTASIA BY THERMOCOAGULATION.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210077: MED RF 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210077
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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