510(k) · Cleared
ClearedVenus VivaTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venus Concept USA, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 1, 2020 as substantially equivalent to K150161 (Venus Concept, Ltd., 2015) and 1 other predicate after a 345-day review. Its family tree reaches back 18 generations to 1995.
- Decided
- Apr 1, 2020
- Review
- 345 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 258 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 2 generations backK111670 Venus Freeze (MP)2 SystemVenus Concept, Ltd. · 2012
- 1 generation backK142910 Legacy BXVenus Concept USA, Inc. · 2014
- This deviceK191065 Venus VivaTMVenus Concept USA, Inc. · 2020
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 4 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 3 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 2 generations backK111670 Venus Freeze (MP)2 SystemVenus Concept, Ltd. · 2012
- 1 generation backK142910 Legacy BXVenus Concept USA, Inc. · 2014
- This deviceK191065 Venus VivaTMVenus Concept USA, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −4 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −3 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −2 | K111670 | Venus Freeze (MP)2 System | Venus Concept, Ltd. | 2012 | — |
| −1 | K142910 | Legacy BX | Venus Concept USA, Inc. | 2014 | — |
| 0 (this device) | K191065 | Venus VivaTM | Venus Concept USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 23 | 0 |
| 2002 | 28 | 0 |
| 2003 | 22 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K150161 | Venus Viva SR DeviceSummary page 4…on 878.4400; (Product code GEI) Classification: Class II Medical Device Classification Panel: General & Plastic Surgery Predicate Devices: Venus Viva TM SR device (K150161) Venus Legacy BX Device (K142910) Venus Concept Ltd. - Venus VivaTM Device - K191065 - Traditional 510(… | 2015 |
| * | K142910 | Legacy BXSummary page 4…ss II Medical Device Classification Panel: General & Plastic Surgery Predicate Devices: Venus Viva TM SR device (K150161) Venus Legacy BX Device (K142910) Venus Concept Ltd. - Venus VivaTM Device - K191065 - Traditional 510(k) Submission… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 258 ancestors have a recall of any class.
- 3 other devices also cite its predicate K150161.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists.
When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.
When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191065: Venus VivaTM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191065
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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