510(k) · Cleared
ClearedSubNovii Advanced Plasma Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cartessa Aesthetics · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 10, 2020 as substantially equivalent to K192813 (Neauvia North America, Inc., 2020) after a 77-day review. Its family tree reaches back 7 generations to 1994. 5 later devices descend from it.
- Decided
- Sep 10, 2020
- Review
- 77 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933002 (1994). 15 ancestors in all, the oldest K823924 (1983). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 6 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 5 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 4 generations backK083452 Erbe Model Vio 300 D with AccessoriesErbe USA, Inc. · 2008
- 3 generations backK134054 Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350…Bovie Medical Corporation · 2014
- 2 generations backK161134 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941…Bovie Medical Corporation · 2016
- 1 generation backK192813 Plasma IQNeauvia North America, Inc. · 2020
- This deviceK201738 SubNovii Advanced Plasma TechnologyCartessa Aesthetics · 2020
- Descendant · cites it directly · 1 of its ownK233123 SilkroHironic Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK233760 Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220493 Plaxpot Multi PlasmaGcs Co. Limited · 2023
- Descendant · cites it directly · 0 of its ownK223440 Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts · 2023
Most influential descendants
Showing 5 of 5 · See all- K233123SilkroHironic Co., Ltd. · 2024 · cites it directly1descendant
- K251334New Doublo 2.0Hironic Co., Ltd. · 2025 · 2 generations on0descendants
- K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024 · cites it directly0descendants
- K220493Plaxpot Multi PlasmaGcs Co. Limited · 2023 · cites it directly0descendants
- K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −6 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −5 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −4 | K083452 | Erbe Model Vio 300 D with Accessories | Erbe USA, Inc. | 2008 | — |
| −3 | K134054 | Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High… | Bovie Medical Corporation | 2014 | — |
| −2 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical… | Bovie Medical Corporation | 2016 | — |
| −1 | K192813 | Plasma IQ | Neauvia North America, Inc. | 2020 | — |
| 0 (this device) | K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020 | — |
| +1 | K233123 | Silkro | Hironic Co., Ltd. | 2024 | — |
| +2 | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
| +1 | K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024 | — |
| +1 | K220493 | Plaxpot Multi Plasma | Gcs Co. Limited | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 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 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 |
|---|---|---|---|
| * | K192813 | Plasma IQSummary page 4…21 CFR 878.4400 (Product Code: GEI) Legally Marketed Predicate Devices: Neauvia North America, Inc. Plasma IQ 510(K) number: K192813 Regulatory Class: Class II Prescription Use Description of the SubNovii: The SubNoviiI Advan… | 2020 |
What descends from it? (5)
4 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 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K233123 (Hironic Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K192813.
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?
The SubNovii 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/K201738 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201738: SubNovii Advanced Plasma Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201738
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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