510(k) · Cleared
Recalled · Class II · 2013Trusculpt
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 Nov 2, 2012 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 67 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- PBX
- Recalls
- 1
- Predicates
- 0
67 later devices descend from it, 2 citing it directly.
- This deviceK122389 TrusculptCutera, Inc. · 2012
- Descendant · cites it directly · 48 of its ownK132949 PellefirmEllman International, Inc. · 2014
- Descendant · cites it directly · 39 of its ownK133739 TrusculptCutera, Inc. · 2014
- Descendant · 2 generations on · 16 of its ownK171262 TempSureCynosure, Inc. · 2017
- Descendant · 2 generations on · 16 of its ownK143040 Exilis XPBTL Industries, Inc. · 2015
- Descendant · 3 generations on · 15 of its ownK182365 TempSure SystemCynosure, Inc. · 2018
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K132949PellefirmEllman International, Inc. · 2014 · cites it directly48descendants
- K133739TrusculptCutera, Inc. · 2014 · cites it directly39descendants
- K171262TempSureCynosure, Inc. · 2017 · 2 generations on16descendants
- K143040Exilis XPBTL Industries, Inc. · 2015 · 2 generations on16descendants
- K182365TempSure SystemCynosure, Inc. · 2018 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122389 | Trusculpt | Cutera, Inc. | 2012 | — |
| +1 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| +1 | K133739 | Trusculpt | Cutera, Inc. | 2014 | — |
| +2 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| +2 | K143040 | Exilis XP | BTL Industries, Inc. | 2015 | — |
| +3 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (67)
See all 672 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2013 | Class II | Z-0427-2014 | Employee error | Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132949 (Ellman International, Inc., 2014) has gone furthest, with 48 descendants 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. 2012, 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 truScuipt infrared(optional) and RE energies are 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 510(k) statement.
https://510kreport.com/device/K122389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122389: Trusculpt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122389
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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