510(k) · Cleared
ClearedV30 System, V20 System, V10 System, V-FR Handpiece
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 Jul 15, 2020 as substantially equivalent to K162363 (Viora, Ltd., 2016) and 3 other predicates after an 85-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Jul 15, 2020
- Review
- 85 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K943450 (1995). 351 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK150035 V10 systemViora, Ltd. · 2015
- 2 generations backK152611 V20 systemViora, Ltd. · 2016
- 1 generation backK162363 V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 2016
- This deviceK201064 V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd. · 2020
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 9 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 8 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 7 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 6 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 5 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 4 generations backK142093 V20 SystemViora, Ltd. · 2014
- 3 generations backK150035 V10 systemViora, Ltd. · 2015
- 2 generations backK152611 V20 systemViora, Ltd. · 2016
- 1 generation backK162363 V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd. · 2016
- This deviceK201064 V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −9 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −8 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −7 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −6 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −5 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −4 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −2 | K152611 | V20 system | Viora, Ltd. | 2016 | — |
| −1 | K162363 | V30 system, V-Form Handpiece BC Medium applicator | Viora, Ltd. | 2016 | — |
| 0 (this device) | K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 22 | 0 |
| 1997 | 23 | 0 |
| 1998 | 22 | 0 |
| 1999 | 14 | 0 |
| 2000 | 26 | 0 |
| 2001 | 28 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 16 | 0 |
| 2005 | 15 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 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? (4)
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 |
|---|---|---|---|
| * | K162363 | V30 system, V-Form Handpiece BC Medium applicatorSummary page 4…1CFR878.4400, 21CFR878.4810 Class: II Panel: General and plastic surgery devices Predicate Viora V30 system (K162363) Device(s): Viora V20 system (K152611) Viora V10 system (K150035) Syner… | 2016 |
| * | K152611 | V20 systemSummary page 4…Class: II Panel: General and plastic surgery devices Predicate Viora V30 system (K162363) Device(s): Viora V20 system (K152611) Viora V10 system (K150035) Syneron Medical Matrix RF Applicator (K090025)… | 2016 |
| * | K150035 | V10 systemSummary page 4…nd plastic surgery devices Predicate Viora V30 system (K162363) Device(s): Viora V20 system (K152611) Viora V10 system (K150035) Syneron Medical Matrix RF Applicator (K090025) Page… | 2015 |
| * | K090025 | Matrix RF ApplicatorSummary page 4…K162363) Device(s): Viora V20 system (K152611) Viora V10 system (K150035) Syneron Medical Matrix RF Applicator (K090025) Page 1 of 6 510(k)… | 2010 |
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 9 months on median.
- 13 of the 351 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162363.
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. 2020, 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 V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V20 system is intended for dermatological procedures.
The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V30 system is intended for dermatological procedures.
The V30 system with V-FR is indicated 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/K201064 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201064: V30 System, V20 System, V10 System, V-FR Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201064
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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