510(k) · Cleared
ClearedCapenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capenergy Medical S.L. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Mar 28, 2023 as substantially equivalent to K191202 (Capenergy Medical S.L., 2020) and 1 other predicate after a 243-day review. Its family tree reaches back 19 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 28, 2023
- Review
- 243 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 111 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 2 generations backK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- 1 generation backK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
- This deviceK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- Descendant · cites it directly · 1 of its ownK241832 Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I)…Boston Aesthetics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
- Descendant · 2 generations on · 0 of its ownK254290 ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II)…Shenzhen Peninsula Medical Group · 2026
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 6 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 5 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 4 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 3 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 2 generations backK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- 1 generation backK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
- This deviceK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
Most influential descendants
Showing 3 of 3 · See all- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc. · 2025 · cites it directly1descendant
- K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026 · cites it directly0descendants
- K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −6 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −5 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −4 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −3 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −2 | K130689 | Symphony RF Generator | Thermigen, Inc. | 2013 | — |
| −1 | K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | 2017 | — |
| 0 (this device) | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023 | — |
| +1 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF… | Boston Aesthetics, Inc. | 2025 | — |
| +1 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026 | — |
| +2 | K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite… | Shenzhen Peninsula Medical Group | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 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 |
|---|---|---|---|
| * | K191202 | Capenergy - C100, C200, C300, C400, C50Summary page 4…Class II REGULATION NUMBER: 21 CFR 878.4400 PRODUCT CODE: PBX SUBSEQUENT PRODUCT CODE: GEI PREDICATE DEVICE Primary Predicate: K191202 Capenergy - C50, C100, C200, C300, C400 Reference Predicate(s): K171094 Thermi Reusable Non-invas… | 2020 |
| * | K171094 | Thermi Reusable Non-invasive RF ElectrodeSummary page 4…NT PRODUCT CODE: GEI PREDICATE DEVICE Primary Predicate: K191202 Capenergy - C50, C100, C200, C300, C400 Reference Predicate(s): K171094 Thermi Reusable Non-invasive RF Electrode DEVICE DESCRIPTION: Capenergy C equipment’s RF System - C25, C50, C100, C200,… | 2017 |
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 28 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 5 of the 111 ancestors have a recall of any class.
- Of its descendants, K241832 (Boston Aesthetics, Inc., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating
for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle
spasms, increase in local circulation, and dermatological procedures.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological
and general surgical procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222260
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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