510(k) · Cleared
ClearedV10 system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viora, Ltd. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on May 1, 2015 as substantially equivalent to K142093 (Viora, Ltd., 2014) and 1 other predicate after a 112-day review. Its family tree reaches back 19 generations to 1995. 31 later devices descend from it.
- Decided
- May 1, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 311 ancestors in all, the oldest K800617 (1980). 31 later devices descend from it, 10 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 2 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 1 generation backK142093 V20 SystemViora, Ltd. · 2014
- This deviceK150035 V10 systemViora, Ltd. · 2015
- Descendant · cites it directly · 18 of its ownK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- Descendant · 2 generations on · 13 of its ownK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- Descendant · 3 generations on · 8 of its ownK183450 EmBody SystemInmode MD, Ltd. · 2019
- Descendant · 4 generations on · 6 of its ownK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- Descendant · 4 generations on · 5 of its ownK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 6 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 5 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 4 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 3 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 2 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 1 generation backK142093 V20 SystemViora, Ltd. · 2014
- This deviceK150035 V10 systemViora, Ltd. · 2015
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K153568InMode Plus SystemInmode MD, Ltd. · 2016 · cites it directly18descendants
- K172302InMode PLUS SystemInmode MD, Ltd. · 2017 · 2 generations on13descendants
- K183450EmBody SystemInmode MD, Ltd. · 2019 · 3 generations on8descendants
- K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021 · 4 generations on6descendants
- K210877Evolve System with the T3 ApplicatorInMode, Ltd. · 2021 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −6 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −5 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −4 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −3 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −1 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| 0 (this device) | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| +1 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| +2 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| +3 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| +4 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| +4 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 21 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 23 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 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 |
|---|---|---|---|
| * | K142093 | V20 SystemSummary page 4…FR878.4400, 21 CFR 890.5660 Class: II Panel: General and plastic surgery devices Predicate Viora V20 system (K142093) Device(s): Viora ReactionTM system (K090221)… | 2014 |
| * | K090221 | Reaction SystemSummary page 4…II Panel: General and plastic surgery devices Predicate Viora V20 system (K142093) Device(s): Viora ReactionTM system (K090221) K150035… | 2009 |
What descends from it? (31)
See all 3110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153568 | InMode Plus System | 2016 | 18 |
| K152611 | V20 system | 2016 | 4 |
| K170637 | sensiFirm | 2017 | 3 |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | 2016 | 3 |
| K161199 | EndyMed Contour Handpiece | 2016 | 2 |
| K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | 2026 | 0 |
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | 2020 | 0 |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | 2020 | 0 |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | 2020 | 0 |
| K161043 | Profound System | 2016 | 0 |
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 8 companies; a new generation was cleared every 9 months on median.
- 11 of the 311 ancestors have a recall of any class.
- Of its descendants, K153568 (Inmode MD, Ltd., 2016) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K142093.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
The Viora V10 system is intended for dermatological procedures.
The V-ST Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The V-Form Handpiece (with BC and FC applicators) is indicated for delivering non thermal RF combined with massage:
• relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and
• temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150035: V10 system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150035
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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