510(k) · Cleared
ClearedVisage Cosmetic Surgery, Model V5000
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 Mar 20, 2000 as substantially equivalent to K981870 (Arthrocare Corp., 1998) and 1 other predicate after a 266-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 20, 2000
- Review
- 266 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K943450 (1995). 16 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 1 generation backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- This deviceK992180 Visage Cosmetic Surgery, Model V5000Arthrocare Corp. · 2000
- Descendant · cites it directly · 1 of its ownK012631 Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
- Descendant · 2 generations on · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006
- Descendant · cites it directly · 0 of its ownK023111 Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001 · cites it directly1descendant
- K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · 2 generations on0descendants
- K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −1 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| 0 (this device) | K992180 | Visage Cosmetic Surgery, Model V5000 | Arthrocare Corp. | 2000 | — |
| +1 | K012631 | Reprocessed Soft Tissue Ablators | Alliance Medical Corp. | 2001 | — |
| +2 | K052692 | Suretek Medical Reprocessed Electrosurgical Electrodes | Suretek Medical | 2006 | — |
| +1 | K023111 | Gyrus Plasma Skin Resurfacing System | Gyrus Medical, 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K981870 | Visage Cosmetic Surgery SystemSummary page 1…78.4400) Trade Name: Visage™ Cosmetic Surgery System Generic/Common Name: Electrosurgical Device and Accessories Predicate Devices Visage Cosmetic Surgery System 1 * K981870 ArthroCare Dermal Electrosurgery System K964849 Establishment of equivalence is based on similarities of intended use, materials… | 1998 |
| * | K964849 | Arthrocare Dermatologic Electrosurgery SystemSummary page 1…ystem Generic/Common Name: Electrosurgical Device and Accessories Predicate Devices Visage Cosmetic Surgery System 1 * K981870 ArthroCare Dermal Electrosurgery System K964849 Establishment of equivalence is based on similarities of intended use, materials, and principle of operations. Additionally, the… | 1997 |
What descends from it? (3)
2 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 5 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K012631 (Alliance Medical Corp., 2001) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K981870.
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 electrosurgical device
intended for general dermatologic surgery that may include skin resurfacing for the
treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and
hemostasis/coagulation. It is intended to be used in procedures using conductive
solutions such as normal saline.
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/K992180 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992180: Visage Cosmetic Surgery, Model V5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992180
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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