510(k) · Cleared
ClearedPrimaeva Medical 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 Feb 28, 2008 as substantially equivalent to K072261 (Primaeva Medical, Inc., 2007) after a 37-day review. Its family tree reaches back 8 generations to 1995. 99 later devices descend from it.
- Decided
- Feb 28, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K943450 (1995). 21 ancestors in all, the oldest K800617 (1980). 99 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 3 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 2 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 1 generation backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- This deviceK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- Descendant · cites it directly · 59 of its ownK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- Descendant · cites it directly · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 2 generations on · 57 of its ownK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- Descendant · 2 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · 3 generations on · 27 of its ownK153727 INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009 · cites it directly59descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · cites it directly57descendants
- K121481Infini Radiofrequency SystemLutronic Corporation · 2013 · 2 generations on57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 2 generations on38descendants
- K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −3 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −2 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −1 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| 0 (this device) | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| +1 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| +1 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +2 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| +2 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +3 | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 22 | 0 |
| 2025 | 13 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K072261 | Finesse SystemSummary page 1…th reusable Electrode Insertion Device and disposable Electrode Cartridge is substantially equivalent to the iPrimaeva Medical Finesse System, a legally marketed device (K072261). F. Device Description The Primaeva Medical System is comprised of' the following components: A reusable radioltequency… | 2007 |
What descends from it? (99)
See all 994 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 13 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K082391 (Primaeva Medical, Inc., 2009) has gone furthest, with 59 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. 2008, 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 Finesse System is indicated 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/K080145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080145: Primaeva Medical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080145
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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