510(k) · Cleared
ClearedLUTRONIC GENIUS Radiofrequency System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 10, 2018 as substantially equivalent to K121481 (Lutronic Corporation, 2013) after a 243-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it.
- Decided
- Dec 10, 2018
- Review
- 243 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K943450 (1995). 24 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 backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 1 generation backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- This deviceK180945 LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation · 2018
- Descendant · cites it directly · 0 of its ownK253484 Lutronic GeniusCynosure Lutronic Technology Corporation · 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 deviceK180945 LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K253484Lutronic GeniusCynosure Lutronic Technology Corporation · 2026 · 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 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −1 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| 0 (this device) | K180945 | LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation | 2018 | — |
| +1 | K253484 | Lutronic Genius | Cynosure Lutronic Technology Corporation | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K121481 | Infini Radiofrequency SystemSummary page 4…Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Panel: General and Plastic Surgery 3. Predicate Devices The INFINI Radiofrequency System (K121481). This predicate device has not been subject to a design-related recall. No reference devices were used in this submission. 4.… | 2013 |
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 |
|---|---|---|---|
| K253484 | Lutronic Genius | 2026 | 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 23 years and passes through 4 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, K253484 (Cynosure Lutronic Technology Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K121481.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for
electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180945: LUTRONIC GENIUS Radiofrequency System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180945
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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