510(k) · Cleared
ClearedVenus Legacy CX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venus Concept, Ltd. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Aug 4, 2015 as substantially equivalent to K090221 (Viora, Ltd., 2009) after a 232-day review. Its family tree reaches back 16 generations to 1995. 17 later devices descend from it.
- Decided
- Aug 4, 2015
- Review
- 232 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 65 ancestors in all, the oldest K800617 (1980). 17 later devices descend from it, 7 citing it directly.
- 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 deviceK143554 Venus Legacy CXVenus Concept, Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK190743 Venus BlissVenus Concept USA, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK191528 Venus Legacy Pro DeviceVenus Concept USA, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK161199 EndyMed Contour HandpieceEndymed Medical, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK242996 EndyMed PRO MAXEndymed Medical, Ltd. · 2025
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 deviceK143554 Venus Legacy CXVenus Concept, Ltd. · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K190743Venus BlissVenus Concept USA, Inc. · 2019 · cites it directly4descendants
- K191528Venus Legacy Pro DeviceVenus Concept USA, Inc. · 2019 · cites it directly3descendants
- K213308Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on2descendants
- K161199EndyMed Contour HandpieceEndymed Medical, Ltd. · 2016 · cites it directly2descendants
- K242996EndyMed PRO MAXEndymed Medical, Ltd. · 2025 · 2 generations on1descendant
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) | K143554 | Venus Legacy CX | Venus Concept, Ltd. | 2015 | — |
| +1 | K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019 | — |
| +1 | K191528 | Venus Legacy Pro Device | Venus Concept USA, Inc. | 2019 | — |
| +2 | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +1 | K161199 | EndyMed Contour Handpiece | Endymed Medical, Ltd. | 2016 | — |
| +2 | K242996 | EndyMed PRO MAX | Endymed Medical, Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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…ice and accessories) (Product code PBX) Classification: Class II Medical Device Predicate Device: Viora Ltd.’s Reaction System (K090221) Intended Use/Indication for Use: The Venus Legacy CX device is intended for the treatment of the following medical conditions;… | 2009 |
| † | K111670 | Venus Freeze (MP)2 System | 2012 |
What descends from it? (17)
See all 177 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 9 months on median.
- 4 of the 65 ancestors have a recall of any class.
- Of its descendants, K190743 (Venus Concept USA, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K090221.
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 Venus Legacy CX device is intended for the treatment of the following medical conditions; using the LB2 and LF2 applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:
Relief of minor muscle aches and pain, relief of muscle spasm
Temporary improvement of local blood circulation
Temporary reduction in the appearance of cellulite
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/K143554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143554: Venus Legacy CX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143554
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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