510(k) · Cleared
ClearedPlasma IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neauvia North America, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 6, 2020 as substantially equivalent to K161134 (Bovie Medical Corporation, 2016) after a 157-day review. Its family tree reaches back 6 generations to 1994. 12 later devices descend from it.
- Decided
- Mar 6, 2020
- Review
- 157 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933002 (1994). 14 ancestors in all, the oldest K823924 (1983). 12 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 5 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 4 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 3 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 2 generations backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- 1 generation backK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- This deviceK192813 Plasma IQNeauvia North America, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK212329 Plasma IQNeauvia North America, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK201738 SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020
- Descendant · 2 generations on · 3 of its ownK223222 Plasma IQNeauvia North America, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK233123 SilkroHironic Co., Ltd. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K212329Plasma IQNeauvia North America, Inc. · 2021 · cites it directly5descendants
- K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020 · cites it directly5descendants
- K223222Plasma IQNeauvia North America, Inc. · 2023 · 2 generations on3descendants
- K241099Plasonic (Plasonic)Hironic Co., Ltd. · 2024 · 3 generations on2descendants
- K233123SilkroHironic Co., Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −5 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −4 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −3 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −2 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| −1 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| 0 (this device) | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| +1 | K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 | — |
| +1 | K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020 | — |
| +2 | K223222 | Plasma IQ | Neauvia North America, Inc. | 2023 | — |
| +3 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +2 | K233123 | Silkro | Hironic Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator…Summary page 4…GEI Regulation: 878.4400 Submission Type: Traditional 510k (Original Submission) Predicate Information Primary Predicate: K161134 – Bovie Derm 941, Electrosurgical Generator Bovie Medical Corporation, Clearwater, FL Contact I… | 2016 |
What descends from it? (12)
See all 123 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 26 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K212329 (Neauvia North America, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K161134.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192813: Plasma IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192813
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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