510(k) · Cleared
Recalled · Class II · 2020VIVACE Electrosurgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sung Hwan E&B Co.,Ltd · OUH Skin Resurfacing Rf Applicator
Cleared on Jan 15, 2016 as substantially equivalent to K121481 (Lutronic Corporation, 2013) after a 331-day review. Its family tree reaches back 11 generations to 1995. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 15, 2016
- Review
- 331 days
- Class
- Class II
- Product code
- OUH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K943450 (1995). 24 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 2 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 backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 1 generation backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- This deviceK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016
- Descendant · cites it directly · 4 of its ownK193070 VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK202415 VirtueRFShenB Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK211562 Virtue RFShenB Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK230968 VYBE RF Electrosurgical SystemShenB Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK262364 Ellian Enigma RF DeviceEllian Corp · 2026
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 backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 1 generation backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- This deviceK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K193070VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021 · cites it directly4descendants
- K202415VirtueRFShenB Co., Ltd. · 2021 · cites it directly3descendants
- K211562Virtue RFShenB Co., Ltd. · 2021 · 2 generations on2descendants
- K230968VYBE RF Electrosurgical SystemShenB Co., Ltd. · 2023 · 2 generations on1descendant
- K262364Ellian Enigma RF DeviceEllian Corp · 2026 · 2 generations on0descendants
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 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −1 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| 0 (this device) | K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016 | — |
| +1 | K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | 2021 | — |
| +1 | K202415 | VirtueRF | ShenB Co., Ltd. | 2021 | — |
| +2 | K211562 | Virtue RF | ShenB Co., Ltd. | 2021 | — |
| +2 | K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | 2023 | — |
| +2 | K262364 | Ellian Enigma RF Device | Ellian Corp | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 OUH? 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? (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 |
|---|---|---|---|
| * | K121481 | Infini Radiofrequency SystemSummary page 4…General and Plastic Surgery III. Predicate Device The VIVACE Electrosurgical System is substantially equivalent to the INFINI Radiofrequency System (K121481). Sung Hwan E&B Co., Ltd. Vivace Electrosurgical System… | 2013 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2020 | Class II | Z-0444-2021 | No Marketing Application | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K193070 (ShenB Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K121481.
How does its category compare?
All OUH devicesOUH Skin Resurfacing Rf Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OUH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OUH
Too few OUH 510(k)s in any year since 2007 to give a median.
Recalls per year · OUH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUH
3in 2025
MAUDE reports naming product code OUH, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.
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/K150409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150409: VIVACE Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150409
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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