510(k) · Cleared
ClearedVIVACE Electrosurgical Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ShenB Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 26, 2021 as substantially equivalent to K150409 (Sung Hwan E&B Co.,Ltd, 2016) after a 539-day review. Its family tree reaches back 12 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 26, 2021
- Review
- 539 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K943450 (1995). 25 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 2 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 1 generation backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- This deviceK193070 VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK230968 VYBE RF Electrosurgical SystemShenB Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK262364 Ellian Enigma RF DeviceEllian Corp · 2026
- Descendant · 2 generations on · 0 of its ownK241535 Vybe RF IIShenB Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233120 CWM-930S, Fixer DV9Chungwoo Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 4 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 3 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 2 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 1 generation backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- This deviceK193070 VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K230968VYBE RF Electrosurgical SystemShenB Co., Ltd. · 2023 · cites it directly1descendant
- K262364Ellian Enigma RF DeviceEllian Corp · 2026 · cites it directly0descendants
- K241535Vybe RF IIShenB Co., Ltd. · 2024 · 2 generations on0descendants
- K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −4 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −3 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −2 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −1 | K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016 | 1 |
| 0 (this device) | K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | 2021 | — |
| +1 | K230968 | VYBE RF Electrosurgical System | ShenB Co., Ltd. | 2023 | — |
| +1 | K262364 | Ellian Enigma RF Device | Ellian Corp | 2026 | — |
| +2 | K241535 | Vybe RF II | ShenB Co., Ltd. | 2024 | — |
| +1 | K233120 | CWM-930S, Fixer DV9 | Chungwoo Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K150409 | VIVACE Electrosurgical SystemSummary page 5…ic Surgery C. PREDICATE DEVICE The VIVACE Electrosurgical System is substantially equivalent to the existing VIVACE Electrosurgical System (primary predicate), K150409. The Secret RF Device K170325 is the reference device to support the 2MHz functionality. D. INTENDED USE The VIVACE Ele… | 2016 |
| † | K170325 | Secret RF | 2017 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K230968 (ShenB Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K150409.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
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 for use with Fitzpatrick Skin Type I
to Skin Type V when using the IMHz setting. The 2MHz setting has not been evaluated for use in the percutaneous
treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation
and hemostasis.
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/K193070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193070: VIVACE Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193070
Report an extraction error
Are you the manufacturer?
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