510(k) · Cleared
ClearedTrusculpt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Sep 5, 2014 as substantially equivalent to K122389 (Cutera, Inc., 2012) after a 270-day review. Its family tree reaches back 1 generation to 2012. 39 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 270 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122389 (2012). 39 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- This deviceK133739 TrusculptCutera, Inc. · 2014
- Descendant · cites it directly · 13 of its ownK162828 Winback Back 3SEWinback USA Corp · 2017
- Descendant · cites it directly · 11 of its ownK161458 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia…Indiba USA, Inc. · 2016
- Descendant · cites it directly · 9 of its ownK151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015 · Recalled
- Descendant · 2 generations on · 8 of its ownK200359 NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020
- Descendant · cites it directly · 5 of its ownK162512 truSculptCutera, Inc. · 2016
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K162828Winback Back 3SEWinback USA Corp · 2017 · cites it directly13descendants
- K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device…Indiba USA, Inc. · 2016 · cites it directly11descendants
- K151296Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015 · cites it directly9descendants
- K200359NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020 · 2 generations on8descendants
- K162512truSculptCutera, Inc. · 2016 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| 0 (this device) | K133739 | Trusculpt | Cutera, Inc. | 2014 | — |
| +1 | K162828 | Winback Back 3SE | Winback USA Corp | 2017 | — |
| +1 | K161458 | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia… | Indiba USA, Inc. | 2016 | — |
| +1 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015 | 1 |
| +2 | K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 | — |
| +1 | K162512 | truSculpt | Cutera, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 11 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K122389 | TrusculptSummary page 4…urgical cutting and coagulation device and accessories, PBX, 21 CFR 878-4400 Legally Marketed Predicate Cutera truSculpt RF Device (K122389) Device: Device Description: The truSculpt device consists of a console, one or more RF… | 2012 |
What descends from it? (39)
See all 395 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?
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. 2014, 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 truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
The truSculpt massage device 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/K133739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133739: Trusculpt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133739
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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