510(k) · Cleared
ClearedIndiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indiba USA, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Oct 3, 2016 as substantially equivalent to K133739 (Cutera, Inc., 2014) and 1 other predicate after a 130-day review. Its family tree reaches back 2 generations to 2012. 11 later devices descend from it.
- Decided
- Oct 3, 2016
- Review
- 130 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K122389 (2012). 3 ancestors in all. 11 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 1 generation backK132949 PellefirmEllman International, Inc. · 2014
- This deviceK161458 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia…Indiba USA, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK191202 Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L. · 2020
- Descendant · 2 generations on · 3 of its ownK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
- Descendant · 3 generations on · 1 of its ownK241832 Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I)…Boston Aesthetics, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK230412 Symmed Elite AestheticTermosalud · 2023
- Descendant · 3 generations on · 0 of its ownK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L. · 2020 · cites it directly4descendants
- K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023 · 2 generations on3descendants
- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc. · 2025 · 3 generations on1descendant
- K230412Symmed Elite AestheticTermosalud · 2023 · cites it directly1descendant
- K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −1 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| 0 (this device) | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia… | Indiba USA, Inc. | 2016 | — |
| +1 | K191202 | Capenergy - C100, C200, C300, C400, C50 | Capenergy Medical S.L. | 2020 | — |
| +2 | K222260 | Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 | Capenergy Medical S.L. | 2023 | — |
| +3 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF… | Boston Aesthetics, Inc. | 2025 | — |
| +1 | K230412 | Symmed Elite Aesthetic | Termosalud | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K133739 | TrusculptSummary page 5…Indiba Diathermia Radiofrequency Devices. Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Applicant K133739 PBX, 878.4400 TruSculpt Cutera Inc. El… | 2014 |
| * | K132949 | PellefirmSummary page 5…Applicant K133739 PBX, 878.4400 TruSculpt Cutera Inc. Ellman International K132949 PBX, 878.4400 PelleFirm System (Cynosure Inc.)… | 2014 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191202 | Capenergy - C100, C200, C300, C400, C50 | 2020 | 4 |
| K230412 | Symmed Elite Aesthetic | 2023 | 1 |
| K242175 | XOD Diathermia Radiofrequency Device | 2025 | 0 |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba… | 2025 | 0 |
| K243164 | INDIBA COMPACT devices | 2024 | 0 |
| K181893 | T-PLUS | 2019 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191202 (Capenergy Medical S.L., 2020) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K133739.
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. 2016, 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 Indiba Diathermia Radiofrequency Devices 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 as stated in the FDA summary.
https://510kreport.com/device/K161458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161458
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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