510(k) · Cleared
ClearedRenuvion/J-Plasma Precise Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apyx Medical Corporation (Formerly Bovie Medical Corporation) · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 30, 2019 as substantially equivalent to K183610 (Bovie Medical Corporation, 2019) and 1 other predicate after a 56-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Jul 30, 2019
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894762 (1989). 22 ancestors in all, the oldest K871435 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 5 generations between
- 3 generations backK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
- 2 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 1 generation backK183610 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation · 2019 · Recalled
- This deviceK191484 Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2019
Show all 9 generations
- Root · 9 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 8 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 7 generations backK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
- 6 generations backK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
- 5 generations backK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
- 4 generations backK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
- 3 generations backK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
- 2 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 1 generation backK183610 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation · 2019 · Recalled
- This deviceK191484 Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −8 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −7 | K030819 | Plasmajet System | Plasma Surgical, Ltd. | 2004 | — |
| −6 | K090586 | Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable… | Bovie Medical | 2009 | — |
| −5 | K112233 | Bovie J-Plasma Handpiece with Retractable Cutting Blade | Bovie Medical Corporation | 2012 | — |
| −4 | K151325 | Bovie J-Plasma Handpiece | Bovie Medical Corporation | 2015 | 1 |
| −3 | K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | 2015 | 5 |
| −2 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency… | Bovie Medical Corporation | 2017 | 6 |
| −1 | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open… | Bovie Medical Corporation | 2019 | 1 |
| 0 (this device) | K191484 | Renuvion/J-Plasma Precise Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Summary page 4…Product Code GEI Predicate Devices: Primary Predicate Device Renuvion®/ J-Plasma® Precise Handpiece (K183610 & K151325) Reference Device… | 2019 |
| * | K151325 | Bovie J-Plasma HandpieceSummary page 4…s: Primary Predicate Device Renuvion®/ J-Plasma® Precise Handpiece (K183610 & K151325) Reference Device Renuvion®/ J-Plasma® Precise Open… | 2015 |
| † | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency… | 2017 |
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 30 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K183610.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures. The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191484: Renuvion/J-Plasma Precise Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191484
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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