510(k) · Cleared
ClearedRenuvion APR 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 15, 2022 as substantially equivalent to K191542 (Bovie Medical Corporation Dba Apyx Medical Corporation, 2019) after a 102-day review. Its family tree reaches back 10 generations to 1989. 3 later devices descend from it.
- Decided
- Jul 15, 2022
- Review
- 102 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894762 (1989). 23 ancestors in all, the oldest K871435 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 6 generations between
- 3 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 2 generations backK183610 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation · 2019 · Recalled
- 1 generation backK191542 Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation · 2019
- This deviceK220970 Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2022
- Descendant · cites it directly · 2 of its ownK223262 Renuvion® APR HandpieceApyx Medical Corporation · 2023
- Descendant · cites it directly · 1 of its ownK230272 Renuvion® APR HandpieceApyx Medical Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK230586 Renuvion® Micro HandpieceApyx Medical Corporation · 2023
Show all 10 generations
- Root · 10 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 9 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 8 generations backK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
- 7 generations backK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
- 6 generations backK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
- 5 generations backK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
- 4 generations backK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
- 3 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 2 generations backK183610 Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open…Bovie Medical Corporation · 2019 · Recalled
- 1 generation backK191542 Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation · 2019
- This deviceK220970 Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation) · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −9 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −8 | K030819 | Plasmajet System | Plasma Surgical, Ltd. | 2004 | — |
| −7 | K090586 | Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable… | Bovie Medical | 2009 | — |
| −6 | K112233 | Bovie J-Plasma Handpiece with Retractable Cutting Blade | Bovie Medical Corporation | 2012 | — |
| −5 | K151325 | Bovie J-Plasma Handpiece | Bovie Medical Corporation | 2015 | 1 |
| −4 | K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | 2015 | 5 |
| −3 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency… | Bovie Medical Corporation | 2017 | 6 |
| −2 | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open… | Bovie Medical Corporation | 2019 | 1 |
| −1 | K191542 | Apyx Plasma/RF Handpiece | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019 | — |
| 0 (this device) | K220970 | Renuvion APR Handpiece | Apyx Medical Corporation (Formerly Bovie Medical Corporation) | 2022 | — |
| +1 | K223262 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023 | — |
| +1 | K230272 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023 | — |
| +2 | K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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 |
|---|---|---|---|
| * | K191542 | Apyx Plasma/RF HandpieceSummary page 4…Product Code GEI Predicate Devices: Predicate Device Apyx Plasma/RF Handpiece (K191542) 2. Proposed Indications for Use: Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or hel… | 2019 |
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?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K223262 (Apyx Medical Corporation, 2023) has gone furthest, with 2 descendants 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. 2022, 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?
Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220970: Renuvion APR Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220970
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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