510(k) · Cleared
ClearedCapenergy C Equipments RF C200 and C400 Drakarian
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 Jul 10, 2026 as substantially equivalent to K192224 (Btl, 2019) and 2 other predicates after a 269-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Jul 10, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 130 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- 2 generations backK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
- 1 generation backK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- This deviceK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 7 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 6 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 5 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 4 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 3 generations backK130689 Symphony RF GeneratorThermigen, Inc. · 2013
- 2 generations backK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
- 1 generation backK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- This deviceK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −7 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −6 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −5 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −4 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −3 | K130689 | Symphony RF Generator | Thermigen, Inc. | 2013 | — |
| −2 | K171094 | Thermi Reusable Non-invasive RF Electrode | Thermgen, L.L.C | 2017 | — |
| −1 | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023 | — |
| 0 (this device) | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 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? (3)
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 |
|---|---|---|---|
| * | K192224 | BTL-899Summary page 5…ULATION NUMBER: 21 CFR 878.4400 PRODUCT CODE: PBX, GEI PREDICATE DEVICES Primary predicate: K192224 BTL-899 from BTL Industries, Inc. Secondary Predicate(s): K163415 Syneron Medical Ltd. SlimShape Sys… | 2019 |
| * | K163415 | SlimShape SystemSummary page 5…PBX, GEI PREDICATE DEVICES Primary predicate: K192224 BTL-899 from BTL Industries, Inc. Secondary Predicate(s): K163415 Syneron Medical Ltd. SlimShape System K222260 Capenergy C Equipment RF System C25, C50, C100, C200, C… | 2017 |
| * | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Summary page 5…ate: K192224 BTL-899 from BTL Industries, Inc. Secondary Predicate(s): K163415 Syneron Medical Ltd. SlimShape System K222260 Capenergy C Equipment RF System C25, C50, C100, C200, C300, C400, C500 by Capenergy Medical SL DEVICE DESCRIPTION:… | 2023 |
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 31 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 130 ancestors have a recall of any class.
- 1 other device also cites its predicate K192224.
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. 2026, 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?
The Capenergy C Equipments RF C200 and C400 Drakarian are intended to provide topical heating for the purpose of elevating tissue temperature for dermatological procedures. The massage device is intended to provide a temporary reduction in the appearance of Cellulite. They are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The Capenergy C Equipments RF C200 and C400 Drakarian are indicated for using for non-invasive reduction of abdominal circumference associated with subcutaneous fat induced by lipolytic processes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253480: Capenergy C Equipments RF C200 and C400 Drakarian.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253480
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026