# K162828: Winback Back 3SE

- Pathway: 510(k) (Traditional)
- Applicant: Winback USA Corp
- Decided: Sep 18, 2017 after 346 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K122389 (2012). 2 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133739: Trusculpt, Cutera, Inc. (2014) Summary page 5.

## Most influential descendants
- K191202: Capenergy - C100, C200, C300, C400, C50 (2020), 4 descendants of its own
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own
- K214090: Back 3 COLOR (2022), 2 descendants of its own
- K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (2025), 1 descendant of its own
- K253480: Capenergy C Equipments RF C200 and C400 Drakarian (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K162828
Methodology: https://510kreport.com/methodology