510(k) · Cleared
ClearedVenus Bliss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venus Concept USA, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Jun 25, 2019 as substantially equivalent to K143554 (Venus Concept, Ltd., 2015) and 1 other predicate after a 95-day review. Its family tree reaches back 21 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 25, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K943450 (1995). 192 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK160470 SculpSureCynosure, Inc. · 2016
- This deviceK190743 Venus BlissVenus Concept USA, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220592 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK252845 Venus Nova (FP-2001)Venus Concept, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233962 ReBorn (1050nm)Lightfective, Ltd. · 2024
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 9 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 8 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 7 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 6 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 5 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 4 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 3 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK160470 SculpSureCynosure, Inc. · 2016
- This deviceK190743 Venus BlissVenus Concept USA, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K213308Venus BlissMAXVenus Concept USA, Inc. · 2022 · cites it directly2descendants
- K220592Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on1descendant
- K252845Venus Nova (FP-2001)Venus Concept, Inc. · 2025 · 3 generations on0descendants
- K233962ReBorn (1050nm)Lightfective, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −9 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −8 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −7 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −6 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −5 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −4 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −3 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −2 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −1 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| 0 (this device) | K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019 | — |
| +1 | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +2 | K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +3 | K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025 | — |
| +1 | K233962 | ReBorn (1050nm) | Lightfective, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 15 | 0 |
| 1997 | 15 | 0 |
| 1998 | 13 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 4 | 0 |
| 2002 | 16 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K143554 | Venus Legacy CXSummary page 5…: PBX, PKT Classification: Class II Medical Device Classification Panel: General & Plastic Surgery Predicate Devices: Venus Legacy CX (K143554) Cynosure’s SculpSure (K160470) Intended Use/Indication for Use: The Venus Bliss device is a diode l… | 2015 |
| * | K160470 | SculpSureSummary page 5…Medical Device Classification Panel: General & Plastic Surgery Predicate Devices: Venus Legacy CX (K143554) Cynosure’s SculpSure (K160470) Intended Use/Indication for Use: The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the ab… | 2016 |
What descends from it? (4)
2 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 24 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 7 of the 192 ancestors have a recall of any class.
- Of its descendants, K213308 (Venus Concept USA, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K143554.
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. 2019, 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 Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy 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 as stated in the FDA summary.
https://510kreport.com/device/K190743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190743: Venus Bliss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190743
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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