510(k) · Cleared
ClearedPlasma Pen (Plasma MD); Plasma Pen (Plasma +)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plasma Concepts · QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction
Cleared on Mar 2, 2023 as substantially equivalent to K201738 (Cartessa Aesthetics, 2020) after a 108-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 2, 2023
- Review
- 108 days
- Class
- Class II
- Product code
- QVJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K933002 (1994). 16 ancestors in all, the oldest K823924 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 7 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 6 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 5 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 4 generations backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- 3 generations backK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- 2 generations backK192813 Plasma IQNeauvia North America, Inc. · 2020
- 1 generation backK201738 SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020
- This deviceK223440 Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −7 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −6 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −5 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −4 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| −3 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| −2 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| −1 | K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020 | — |
| 0 (this device) | K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | Plasma Concepts | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 K233760 Mjolnir Pro. (Multi–electrode plasma)score 12.6 · 20 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K201738 | SubNovii Advanced Plasma TechnologySummary page 4…cessories Regulation Number: 21 CFR 878.4400, Class II Classification Product Code: GEI Predicate Device: K201738: SubNovii Advanced Plasma Technology Device Description: The Plasma Pen utilizes a treatment method called plasma sublimation, w… | 2020 |
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 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 16 ancestors has a recall.
- 3 other devices also cite its predicate K201738.
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. 2023, 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?
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223440: Plasma Pen (Plasma MD); Plasma Pen (Plasma +).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223440
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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