510(k) · Cleared
ClearedVenus BlissMAX
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 Jan 12, 2022 as substantially equivalent to K190743 (Venus Concept USA, Inc., 2019) and 1 other predicate after a 100-day review. Its family tree reaches back 22 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 12, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K943450 (1995). 200 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK160470 SculpSureCynosure, Inc. · 2016
- 1 generation backK190743 Venus BlissVenus Concept USA, Inc. · 2019
- This deviceK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK220592 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252845 Venus Nova (FP-2001)Venus Concept, Inc. · 2025
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 backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 10 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 9 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 8 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 7 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 6 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 5 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 4 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 3 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK160470 SculpSureCynosure, Inc. · 2016
- 1 generation backK190743 Venus BlissVenus Concept USA, Inc. · 2019
- This deviceK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView 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 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −10 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −9 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −8 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −7 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −6 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −5 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −4 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −3 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −2 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| −1 | K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019 | — |
| 0 (this device) | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +1 | K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +2 | K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025 | — |
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 | 11 | 0 |
| 1995 | 10 | 0 |
| 1996 | 15 | 0 |
| 1997 | 15 | 0 |
| 1998 | 13 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 4 | 0 |
| 2002 | 17 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 4 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K190743 | Venus BlissSummary page 4…tioning Product Codes: PKT, PBX, NGX Classification: Class II Medical Device Classification Panel: Physical Medicine Predicate Devices: Venus Bliss (K190743) Body System (K182440) Reference Devices: InMode System with Tone Applicator (K192249) T… | 2019 |
| * | K182440 | Body SystemSummary page 4…Classification: Class II Medical Device Classification Panel: Physical Medicine Predicate Devices: Venus Bliss (K190743) Body System (K182440) Reference Devices: InMode System with Tone Applicator (K192249) Traditional 510(k) Submission – Venus BlissMAX… | 2019 |
| † | K192249 | InMode System with Tone Applicator | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220592 | Venus BlissMAX | 2022 | 1 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 200 ancestors have a recall of any class.
- Of its descendants, K220592 (Venus Concept USA, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K190743.
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. 2022, 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 BlissMAX 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 BlissMAX 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…
Read the full statement (151 words)
The Venus BlissMAX 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 BlissMAX 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
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
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/K213308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213308: Venus BlissMAX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213308
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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