510(k) · Cleared
ClearedVybe RF II
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 Sep 25, 2024 as substantially equivalent to K211562 (ShenB Co., Ltd., 2021) and 1 other predicate after a 118-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Sep 25, 2024
- Review
- 118 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- 2 generations backK202415 VirtueRFShenB Co., Ltd. · 2021
- 1 generation backK211562 Virtue RFShenB Co., Ltd. · 2021
- This deviceK241535 Vybe RF IIShenB Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 6 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 5 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 4 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 3 generations backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- 2 generations backK202415 VirtueRFShenB Co., Ltd. · 2021
- 1 generation backK211562 Virtue RFShenB Co., Ltd. · 2021
- This deviceK241535 Vybe RF IIShenB Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −6 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −5 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −4 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −3 | K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016 | 1 |
| −2 | K202415 | VirtueRF | ShenB Co., Ltd. | 2021 | — |
| −1 | K211562 | Virtue RF | ShenB Co., Ltd. | 2021 | — |
| 0 (this device) | K241535 | Vybe RF II | ShenB 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 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K211562 | Virtue RFSummary page 5…tion Number 878.4400 Product Code GEI Regulatory Class II Legally Marketed Predicate Devices Virtue RF (K211562) Vybe RF (K230986) Device Description: VYBE RF II is a High Frequency Electrosurgical Unit… | 2021 |
| * | K230968 | VYBE RF Electrosurgical System Our reading of the summary gave K230986, FDA’s number for Bladder Scanner (Avantsonic Technology Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Vybe RF”. | 2023 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K211562.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial…
Read the full statement (146 words)
The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and
hemostasis.
Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use
in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the
Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial wrinkles in
Skin Types I-V.
Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use
in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece
with 2MHz functionality is not intended to treat wrinkles.
One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and
general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat
wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241535: Vybe RF II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241535
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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