510(k) · Cleared
ClearedVisage Cosmetic Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 20, 1998 as substantially equivalent to K964849 (Arthrocare Corp., 1997) and 3 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1995. 1,073 later devices descend from it.
- Decided
- Aug 20, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K943450 (1995). 15 ancestors in all, the oldest K800617 (1980). 1,073 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 4 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 2 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 1 generation backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- This deviceK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- Descendant · cites it directly · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · 2 generations on · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- Descendant · 2 generations on · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · 2 generations on · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · 3 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
Showing 5 of 1,073 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,073 · See all- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · cites it directly1,069descendants
- K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · 2 generations on800descendants
- K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · 2 generations on799descendants
- K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · 2 generations on789descendants
- K030142Thermacool TC SystemThermage, Inc. · 2003 · 3 generations on773descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −4 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −2 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −1 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| 0 (this device) | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| +1 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +2 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| +2 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +2 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
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 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 12 | 0 |
| 2004 | 5 | 0 |
| 2005 | 15 | 0 |
| 2006 | 9 | 0 |
| 2007 | 15 | 0 |
| 2008 | 30 | 0 |
| 2009 | 25 | 0 |
| 2010 | 27 | 0 |
| 2011 | 18 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 43 | 0 |
| 2016 | 56 | 0 |
| 2017 | 60 | 0 |
| 2018 | 49 | 0 |
| 2019 | 40 | 0 |
| 2020 | 54 | 0 |
| 2021 | 60 | 0 |
| 2022 | 80 | 0 |
| 2023 | 72 | 0 |
| 2024 | 97 | 0 |
| 2025 | 128 | 0 |
| 2026 | 76 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964849 | Arthrocare Dermatologic Electrosurgery SystemSummary page 1…cal Cutting and Coagulation Device and name: Accessories (21 CFR 878.4400) B. Predicate devices Device : Premarket Notification ArthroCare Dermal Electrosurgery System K964849, 04/14/97 ArthroCare Arthroscopic Electrosurgery System K963123, 10/08/96 (System 2000) ArthroCare Sinus Electrosurgery System K… | 1997 |
| * | K963123 | Arthrocare Arthroscopic Eletrosurgery System (Model 980)Summary page 1…878.4400) B. Predicate devices Device : Premarket Notification ArthroCare Dermal Electrosurgery System K964849, 04/14/97 ArthroCare Arthroscopic Electrosurgery System K963123, 10/08/96 (System 2000) ArthroCare Sinus Electrosurgery System K973478, 1/9/98 (System 2000) ConMed Hyfrecator Plus K800617, 05… | 1996 |
| * | K973478 | Arthrocare Sinus Electrosurgery SystemSummary page 1…Care Dermal Electrosurgery System K964849, 04/14/97 ArthroCare Arthroscopic Electrosurgery System K963123, 10/08/96 (System 2000) ArthroCare Sinus Electrosurgery System K973478, 1/9/98 (System 2000) ConMed Hyfrecator Plus K800617, 05/02/80 C. Device description The Visage Cosmetic Surgery System is sho… | 1998 |
| * | K800617 | Hyfrecator, #733Summary page 1…throCare Arthroscopic Electrosurgery System K963123, 10/08/96 (System 2000) ArthroCare Sinus Electrosurgery System K973478, 1/9/98 (System 2000) ConMed Hyfrecator Plus K800617, 05/02/80 C. Device description The Visage Cosmetic Surgery System is shown in Figure 1 (Figures Section), and includes three c… | 1980 |
What descends from it? (1,073)
See all 1,0734 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 3 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K000944 (Thermage, Inc., 2000) has gone furthest, with 1,069 descendants of its own.
- 4 other devices also cite its predicate K964849.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Visage Cosmetic Surgery System is a bipolar high frequency electrosurglcal device intended for general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer’s Lactate as an irrigant.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981870: Visage Cosmetic Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981870
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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