510(k) · Cleared
ClearedJETT PLASMA Medical II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compex, Spol, S.R.O. · QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction
Cleared on Mar 14, 2023 after a 530-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 14, 2023
- Review
- 530 days
- Class
- Class II
- Product code
- QVJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K213247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213247: JETT PLASMA Medical II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026