510(k) · Cleared
ClearedEllian Enigma RF Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellian Corp · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 2, 2026 as substantially equivalent to K193070 (ShenB Co., Ltd., 2021) after a 54-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Sep 2, 2026
- Review
- 54 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 2 generations backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- 1 generation backK193070 VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021
- This deviceK262364 Ellian Enigma RF DeviceEllian Corp · 2026
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 5 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 4 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 3 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 2 generations backK150409 VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd · 2016 · Recalled
- 1 generation backK193070 VIVACE Electrosurgical DeviceShenB Co., Ltd. · 2021
- This deviceK262364 Ellian Enigma RF DeviceEllian Corp · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −5 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −4 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −3 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −2 | K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016 | 1 |
| −1 | K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K193070 | VIVACE Electrosurgical DeviceSummary page 5…iew Panel General and Plastic Surgery Predicate Device VIVACE Electrosurgical System, ShenB Co., Ltd. K193070 C. INTENDED USE / INDICATIONS FOR USE The Enigma RF Device is intended for use in dermatologic procedures for electrocoagulati… | 2021 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K193070.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Enigma RF Device is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K262364: Ellian Enigma RF Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K262364
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026