510(k) · Cleared
ClearedRenuvion Dermal Handpiece, Renuvion Dermal System
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 May 25, 2022 as substantially equivalent to K132754 (Energist, Ltd., 2013) after a 362-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- May 25, 2022
- Review
- 362 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 149 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- 2 generations backK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- 1 generation backK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- This deviceK211652 Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 5 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 4 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 3 generations backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- 2 generations backK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- 1 generation backK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- This deviceK211652 Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −5 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −4 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −3 | K073111 | Portrait PSR, Model 745915 | Rhytec Incorporated | 2008 | — |
| −2 | K082197 | Rhytec, Inc., Portrait PSR | Rhytec Incorporated | 2008 | — |
| −1 | K132754 | Neogen PSR System | Energist, Ltd. | 2013 | — |
| 0 (this device) | K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 9 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K132754 | Neogen PSR SystemSummary page 4…Product Code GEI Predicate Devices: Predicate Device NeoGen PSR System, Energist Ltd (K132754) - (formerly Portrait PSR System, Rhytec Inc.) 2. Indications for Use The Renuvion®… | 2013 |
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 27 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 8 of the 149 ancestors have a recall of any class.
- 1 other device also cites its predicate K132754.
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?
The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis.
The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211652: Renuvion Dermal Handpiece, Renuvion Dermal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211652
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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