510(k) · Cleared
ClearedVenus Viva SR Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venus Concept, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 12, 2015 as substantially equivalent to K102461 (Invasix, Ltd., 2011) after a 109-day review. Its family tree reaches back 17 generations to 1995. 9 later devices descend from it.
- Decided
- May 12, 2015
- Review
- 109 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 225 ancestors in all, the oldest K800617 (1980). 9 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 2 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 1 generation backK102461 FractoraInvasix, Ltd. · 2011
- This deviceK150161 Venus Viva SR DeviceVenus Concept, Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK201164 Venus Viva MD DeviceVenus Concept USA, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK212107 ReversoIntelis Instruments, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK202988 Tixel SystemNovoxel, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK153717 Venus Versa SystemVenus Concept, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK243139 Reverso Pro SystemIndiba S. A. U. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 5 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 4 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 3 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 2 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 1 generation backK102461 FractoraInvasix, Ltd. · 2011
- This deviceK150161 Venus Viva SR DeviceVenus Concept, Ltd. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K201164Venus Viva MD DeviceVenus Concept USA, Inc. · 2020 · cites it directly3descendants
- K212107ReversoIntelis Instruments, Ltd. · 2021 · 2 generations on1descendant
- K202988Tixel SystemNovoxel, Ltd. · 2021 · cites it directly1descendant
- K153717Venus Versa SystemVenus Concept, Ltd. · 2016 · cites it directly1descendant
- K243139Reverso Pro SystemIndiba S. A. U. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −5 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −4 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −3 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −2 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −1 | K102461 | Fractora | Invasix, Ltd. | 2011 | — |
| 0 (this device) | K150161 | Venus Viva SR Device | Venus Concept, Ltd. | 2015 | — |
| +1 | K201164 | Venus Viva MD Device | Venus Concept USA, Inc. | 2020 | — |
| +2 | K212107 | Reverso | Intelis Instruments, Ltd. | 2021 | — |
| +1 | K202988 | Tixel System | Novoxel, Ltd. | 2021 | — |
| +1 | K153717 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
| +2 | K243139 | Reverso Pro System | Indiba S. A. U. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 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 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 14 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 20 | 0 |
| 2002 | 25 | 0 |
| 2003 | 20 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K102461 | FractoraSummary page 4…cal cutting and coagulation device and accessories (21 C.F.R. 878.4400; Product Code GEI) Predicate and Reference Devices Invasix Ltd.’s Fractora device (K102461) (Primary Predicate) Reference Devices: Primaeva Medical's Miratone System (K082391), Syneron Medical's eMatrix app… | 2011 |
| † | K082391 | Primaeva Medical Renesis System | 2009 |
| † | K101321 | Ematrix CO2 | 2010 |
| † | K110672 | Etwo Skin Treatment System | 2011 |
| † | K111670 | Venus Freeze (MP)2 System | 2012 |
| † | K100586 | Venus Freeze System | 2010 |
| † | K140629 | Venus Swan (MP)2 | 2014 |
| † | K111784 | Venus Swan System | 2011 |
What descends from it? (9)
4 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 20 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 225 ancestors have a recall of any class.
- Of its descendants, K201164 (Venus Concept USA, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K102461.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SR system is intended for dermatological procedures requiring ablation and
resurfacing of the skin.
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/K150161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150161: Venus Viva SR Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150161
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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