510(k) · Cleared
ClearedMygen V-1000 RF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
RF Medical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 11, 2018 after a 239-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 11, 2018
- Review
- 239 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK180999 Mygen V-1000 RF SystemRF Medical Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK193355 Electrodes Handpieces for Mygen V-1000 RF SystemRF Medical Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK232763 Electrode Handpieces (VCT, RFTV, BMDT series)RF Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221277 Mygen M-3004 RF Generator M-3004RF Medical Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K193355Electrodes Handpieces for Mygen V-1000 RF SystemRF Medical Co., Ltd. · 2020 · cites it directly1descendant
- K232763Electrode Handpieces (VCT, RFTV, BMDT series)RF Medical Co., Ltd. · 2023 · 2 generations on0descendants
- K221277Mygen M-3004 RF Generator M-3004RF Medical Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K180999 | Mygen V-1000 RF System | RF Medical Co., Ltd. | 2018 | — |
| +1 | K193355 | Electrodes Handpieces for Mygen V-1000 RF System | RF Medical Co., Ltd. | 2020 | — |
| +2 | K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | RF Medical Co., Ltd. | 2023 | — |
| +1 | K221277 | Mygen M-3004 RF Generator M-3004 | RF Medical Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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?
- Of its descendants, K193355 (RF Medical Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K180999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180999: Mygen V-1000 RF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180999
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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