510(k) · Cleared
ClearedWinback Back 3SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winback USA Corp · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Sep 18, 2017 as substantially equivalent to K133739 (Cutera, Inc., 2014) after a 346-day review. Its family tree reaches back 2 generations to 2012. 13 later devices descend from it.
- Decided
- Sep 18, 2017
- Review
- 346 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K122389 (2012). 13 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 1 generation backK133739 TrusculptCutera, Inc. · 2014
- This deviceK162828 Winback Back 3SEWinback USA Corp · 2017
- 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 · cites it directly · 2 of its ownK214090 Back 3 COLORSwims America Corp · 2022
- Descendant · 3 generations on · 1 of its ownK241832 Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I)…Boston Aesthetics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253480 Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · 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
- K214090Back 3 COLORSwims America Corp · 2022 · cites it directly2descendants
- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc. · 2025 · 3 generations on1descendant
- 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 | K133739 | Trusculpt | Cutera, Inc. | 2014 | — |
| 0 (this device) | K162828 | Winback Back 3SE | Winback USA Corp | 2017 | — |
| +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 | — |
| +1 | K214090 | Back 3 COLOR | Swims America Corp | 2022 | — |
| +3 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF… | Boston Aesthetics, Inc. | 2025 | — |
| +3 | K253480 | Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K133739 | TrusculptSummary page 5…al Equivalence/Technological Characteristics: The Winback 3SE device is substantially equivalent to the following device: Predicate device clearance: K133739 Trade Name: truSculpt Company: Cutera Incorporated Both devices are cart mounted consoles with el… | 2014 |
What descends from it? (13)
See all 137 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 2 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. 2017, 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 Winback Back 3SE device 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 Winback Back 3SE massage device 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/K162828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162828: Winback Back 3SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162828
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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