510(k) · Cleared
ClearedMjolnir Pro. (Multi–electrode plasma)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Leaflife Technology Co., Ltd. · QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction
Cleared on Feb 20, 2024 as substantially equivalent to K212329 (Neauvia North America, Inc., 2021) and 2 other predicates after an 88-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Feb 20, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- QVJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 292 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- 2 generations backK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- 1 generation backK201520 The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021
- This deviceK233760 Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 8 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 7 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 6 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 5 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 4 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 3 generations backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- 2 generations backK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- 1 generation backK201520 The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021
- This deviceK233760 Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −8 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −7 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −6 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −5 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −4 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −3 | K120513 | Glow by Endymed | Endymed Medical, Ltd. | 2012 | — |
| −2 | K121150 | Alma Lasers Family of Pixel RF Tips | Alma Lasers, Inc. | 2012 | — |
| −1 | K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021 | — |
| 0 (this device) | K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 15 | 0 |
| 1996 | 22 | 0 |
| 1997 | 23 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 31 | 0 |
| 2003 | 25 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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 QVJ? 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 QVJ device
- #1 K220493 Plaxpot Multi Plasmascore 8.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K212329 | Plasma IQSummary page 5…lation Class: II Product Code: QVJ III. Legally Marketed Predicate Device Predicate device (Primary) 510(k) Number: K212329 Device Name: Plasma IQ Manufacturer: Neauvia North America, Inc Predicate device (1#) 510(k)… | 2021 |
| * | K201738 | SubNovii Advanced Plasma TechnologySummary page 5…K212329 Device Name: Plasma IQ Manufacturer: Neauvia North America, Inc Predicate device (1#) 510(k) Number: K201738 Device Name: SubNovii Advanced Plasma Technology Manufacturer: Cartessa Aesthetics Predicate… | 2020 |
| * | K201520 | The Alma Opus System, Colibri Applicator and TipsSummary page 5…ce Name: SubNovii Advanced Plasma Technology Manufacturer: Cartessa Aesthetics Predicate device (2#) 510(k) Number: K201520 Device Name: The Alma Opus System, Colibri Applicator and Tips Manufacturer: Alma Lasers Inc… | 2021 |
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 10 of the 292 ancestors have a recall of any class.
- 1 other device also cites its predicate K212329.
How does its category compare?
All QVJ devicesQVJ Low Power Electrosurgical Devices For Skin Lesion Destruction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QVJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QVJ
530in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QVJ
No recall names QVJ since 2007.
Adverse event reports per year · QVJ
No MAUDE report names QVJ since 2007.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 530 | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi–electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233760: Mjolnir Pro. (Multi–electrode plasma).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233760
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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