510(k) · Cleared
ClearedViora V-Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viora, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 21, 2014 as substantially equivalent to K090221 (Viora, Ltd., 2009) after a 99-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Oct 21, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 65 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 2 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 1 generation backK090221 Reaction SystemViora, Ltd. · 2009
- This deviceK141904 Viora V-TouchViora, Ltd. · 2014
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 4 generations backK070092 Modification to Velasmooth, ShaperSyneron Medical, Ltd. · 2007
- 3 generations backK071872 VelashapeSyneron Medical, Ltd. · 2007
- 2 generations backK080300 Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
- 1 generation backK090221 Reaction SystemViora, Ltd. · 2009
- This deviceK141904 Viora V-TouchViora, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −4 | K070092 | Modification to Velasmooth, Shaper | Syneron Medical, Ltd. | 2007 | — |
| −3 | K071872 | Velashape | Syneron Medical, Ltd. | 2007 | — |
| −2 | K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera, Inc. | 2008 | — |
| −1 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| 0 (this device) | K141904 | Viora V-Touch | Viora, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K090221 | Reaction SystemSummary page 4…provides the treatments using the following specially- designed applicator: The ST applicator, which was cleared for Viora’s Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain,… | 2009 |
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 19 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 65 ancestors have a recall of any class.
- 6 other devices also cite its predicate K090221.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 V-Touch is intended for dermatological procedures.
The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141904: Viora V-Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141904
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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