# K133739: Trusculpt

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Sep 5, 2014 after 270 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: 1 generation back to K122389 (2012). 1 ancestor in all.
39 later devices descend from it; 5 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122389: Trusculpt, Cutera, Inc. (2012) Summary page 4.

## Most influential descendants
- K162828: Winback Back 3SE (2017), 13 descendants of its own
- K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care (2016), 11 descendants of its own
- K151296: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) (2015), 9 descendants of its own
- K200359: NuEra Tight, NuEra Tight EMS (2020), 8 descendants of its own
- K162512: truSculpt (2016), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K133739
Methodology: https://510kreport.com/methodology