510(k) · Cleared
ClearedCapenergy - C100, C200, C300, C400, C50
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 Feb 11, 2020 as substantially equivalent to K161458 (Indiba USA, Inc., 2016) and 1 other predicate after a 281-day review. Its family tree reaches back 3 generations to 2012. 4 later devices descend from it.
- Decided
- Feb 11, 2020
- Review
- 281 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K122389 (2012). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 2 generations backK132949 PellefirmEllman International, Inc. · 2014
- 1 generation backK161458 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia…Indiba USA, Inc. · 2016
- This deviceK191202 Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L. · 2020
- Descendant · cites it directly · 3 of its ownK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- Descendant · 2 generations on · 1 of its ownK241832 Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I)…Boston Aesthetics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
- Descendant · 3 generations on · 0 of its ownK254290 ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II)…Shenzhen Peninsula Medical Group · 2026
Most influential descendants
Showing 4 of 4 · See all- K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023 · cites it directly3descendants
- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc. · 2025 · 2 generations on1descendant
- K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026 · 2 generations on0descendants
- K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −2 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −1 | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia… | Indiba USA, Inc. | 2016 | — |
| 0 (this device) | K191202 | Capenergy - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | 2020 | — |
| +1 | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023 | — |
| +2 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF… | Boston Aesthetics, Inc. | 2025 | — |
| +2 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device…Summary page 4…duced Heat REGULATION NUMBER: 21 CFR 878.4400 PRODUCT CODE: PBX PREDICATE DEVICE(S): Indiba Diathermia Radiofrequency Device - K161458 Winback Back 3SE - K162828 DEVICE DESCRIPTION: The proposed device is an equipment for diatherm… | 2016 |
| * | K162828 | Winback Back 3SESummary page 4…PRODUCT CODE: PBX PREDICATE DEVICE(S): Indiba Diathermia Radiofrequency Device - K161458 Winback Back 3SE - K162828 DEVICE DESCRIPTION: The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating elec… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | 2023 | 3 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K222260 (Capenergy Medical S.L., 2023) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K161458.
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. 2020, 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 Devices - C100, C200, C300, C400, C50 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.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191202: Capenergy - C100, C200, C300, C400, C50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191202
Report an extraction error
Are you the manufacturer?
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