510(k) · Cleared
ClearedPrimaeva Medical Renesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primaeva Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 1, 2009 as substantially equivalent to K072261 (Primaeva Medical, Inc., 2007) and 1 other predicate after a 378-day review. Its family tree reaches back 9 generations to 1995. 59 later devices descend from it.
- Decided
- Sep 1, 2009
- Review
- 378 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K943450 (1995). 22 ancestors in all, the oldest K800617 (1980). 59 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 1 generation backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- This deviceK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- Descendant · cites it directly · 57 of its ownK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- Descendant · 2 generations on · 27 of its ownK153727 INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016
- Descendant · 3 generations on · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
- Descendant · 4 generations on · 9 of its ownK201685 PotenzaJeisys Medical, Inc. · 2021
- Descendant · 2 generations on · 9 of its ownK180359 BTL-FR2000BTL Industries, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 4 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 2 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 1 generation backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- This deviceK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K121481Infini Radiofrequency SystemLutronic Corporation · 2013 · cites it directly57descendants
- K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016 · 2 generations on27descendants
- K192545PotenzaJeisys Medical Incorporated · 2020 · 3 generations on20descendants
- K201685PotenzaJeisys Medical, Inc. · 2021 · 4 generations on9descendants
- K180359BTL-FR2000BTL Industries, Inc. · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −4 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −3 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −2 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −1 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| 0 (this device) | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| +1 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| +2 | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016 | — |
| +3 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
| +4 | K201685 | Potenza | Jeisys Medical, Inc. | 2021 | — |
| +2 | K180359 | BTL-FR2000 | BTL Industries, Inc. | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 13 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K072261 | Finesse SystemSummary page 1…gical cuffing and coagulation device and accessories Product Code: GEl Predicate Devices: Primaeva Medical Finesse System - K072261 Primaeva Medical System - K080145 Device Description: The Primaeva Medical Miratone System is comprised… | 2007 |
| * | K080145 | Primaeva Medical SystemSummary page 1…ce and accessories Product Code: GEl Predicate Devices: Primaeva Medical Finesse System - K072261 Primaeva Medical System - K080145 Device Description: The Primaeva Medical Miratone System is comprised of the following components: A reusabl… | 2008 |
What descends from it? (59)
See all 592 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 14 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 22 ancestors have a recall of any class.
- Of its descendants, K121481 (Lutronic Corporation, 2013) has gone furthest, with 57 descendants of its own.
- 1 other device also cites its predicate K072261.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Primaeva Medical Miratone System is indicated for use in dermatologic and
general surgical procedures for electrocoagulation and hemostasis, and the
percutaneous treatment of facial wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082391: Primaeva Medical Renesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082391
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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