510(k) Report

510(k) · Cleared

Cleared

Finesse System

K072261510(k) TraditionalCleared Dec 26, 2007134-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Primaeva Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 26, 2007 as substantially equivalent to K000944 (Thermage, Inc., 2000) and 3 other predicates after a 134-day review. Its family tree reaches back 7 generations to 1995. 100 later devices descend from it.

Decided
Dec 26, 2007
Review
134 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K943450 (1995). 20 ancestors in all, the oldest K800617 (1980). 100 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1996: 5 other ancestors1980: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors2009: 2 descendants cleared2008: 1 descendant cleared2016: 5 descendants cleared2014: 1 descendant cleared2013: 2 descendants cleared2012: 1 descendant cleared2021: 8 descendants cleared2017: 4 descendants cleared2023: 7 descendants cleared2018: 5 descendants cleared2024: 22 descendants cleared2025: 13 descendants cleared2022: 8 descendants cleared2020: 6 descendants cleared2019: 3 descendants cleared2026: 12 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 200019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 7 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 16 descendants4 generations forward: 16 descendants5 generations forward: 21 descendants6 generations forward: 22 descendants7 generations forward: 12 descendants8 generations forward: 5 descendants9 generations forward: 2 descendants K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−50+5
  1. Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 3 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 2 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 1 generation backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. This deviceK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
  9. Descendant · cites it directly · 99 of its ownK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
  10. Descendant · cites it directly · 59 of its ownK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
  11. Descendant · 2 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
  12. Descendant · 2 generations on · 57 of its ownK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
  13. Descendant · 3 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018

Showing 5 of 100 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22012: 12013: 22014: 12016: 52017: 42018: 52019: 32020: 62021: 82022: 82023: 72024: 222025: 132026: 12
2008high 22 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 100 · See all
  • K080145Primaeva Medical SystemPrimaeva Medical, Inc. · 2008 · cites it directly99descendants
  • K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009 · cites it directly59descendants
  • K130501IntensifEndymed Medical, Ltd. · 2014 · 2 generations on57descendants
  • K121481Infini Radiofrequency SystemLutronic Corporation · 2013 · 2 generations on57descendants
  • K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 3 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−6K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−5K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−4K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−3K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−2K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−1K000944Thermage Thermacool SystemThermage, Inc.2000—
0 (this device)K072261Finesse SystemPrimaeva Medical, Inc.2007—
+1K080145Primaeva Medical SystemPrimaeva Medical, Inc.2008—
+1K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.2009—
+2K130501IntensifEndymed Medical, Ltd.2014—
+2K121481Infini Radiofrequency SystemLutronic Corporation2013—
+3K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199220
199410
199520
199650
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201210
201320
201410
201650
201740
201850
201930
202060
202180
202280
202370
2024220
2025130
2026120
FIG. 1 — Lineage of K072261, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K000944Thermage Thermacool System
Summary page 1
…FR 878.4400, Product Code GEl) E. Predicate Devices The Primaeva Medical Finesse System is substantially equivalent to the Thermage ThermaCool System (K000944 and K003183), ArthroCare Visage Cosmetic Surgery System (K981870), and Radionics Cool-Tip RF System (K984552). F.…
Thermage, Inc.2000—
*K003183Thermage Thermacool II System
Summary page 1
…Product Code GEl) E. Predicate Devices The Primaeva Medical Finesse System is substantially equivalent to the Thermage ThermaCool System (K000944 and K003183), ArthroCare Visage Cosmetic Surgery System (K981870), and Radionics Cool-Tip RF System (K984552). F. Device D…
Thermage, Inc.2000—
*K981870Visage Cosmetic Surgery System
Summary page 1
…aeva Medical Finesse System is substantially equivalent to the Thermage ThermaCool System (K000944 and K003183), ArthroCare Visage Cosmetic Surgery System (K981870), and Radionics Cool-Tip RF System (K984552). F. Device Description The Primaeva Medical Finesse System is com…
Arthrocare Corp.1998—
*K984552Cool-Tip RF System
Summary page 1
…lent to the Thermage ThermaCool System (K000944 and K003183), ArthroCare Visage Cosmetic Surgery System (K981870), and Radionics Cool-Tip RF System (K984552). F. Device Description The Primaeva Medical Finesse System is comprised of four primary components; an RF Gen…
Radionics, Inc.19991

Also cleared against K000944: 9 other devices →

What descends from it? (100)

See all 100

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899
K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959

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 12 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 2 of the 20 ancestors have a recall of any class.
  • Of its descendants, K080145 (Primaeva Medical, Inc., 2008) has gone furthest, with 99 descendants of its own.
  • 9 other devices also cite its predicate K000944.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K000944

9 other devices cite the same predicate.

  • K130689Symphony RF GeneratorThermigen, Inc. · 2013
  • K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc. · 2008
  • K043402Thermage Thermacool SystemThermage, Inc. · 2005
  • K033942Thermage Thermacool SystemThermage, Inc. · 2004
  • K021402Thermage Thermacool TC SystemThermage, Inc. · 2002
  • K022266Aurora SRSyneron Medical, Ltd. · 2002

More from Primaeva Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
  • K080145Primaeva Medical SystemPrimaeva Medical, Inc. · 2008

Recent decisions in GEI

The GEI category page

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https://510kreport.com/device/K072261 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072261: Finesse System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072261

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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