# K122389: Trusculpt

- Pathway: 510(k) (Special)
- Applicant: Cutera, Inc.
- Decided: Nov 2, 2012 after 87 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132949: Pellefirm (2014), 48 descendants of its own
- K133739: Trusculpt (2014), 39 descendants of its own
- K171262: TempSure (2017), 16 descendants of its own
- K143040: Exilis XP (2015), 16 descendants of its own
- K182365: TempSure System (2018), 15 descendants of its own

## Recalls of this device
- Oct 16, 2013 · Class II · Z-0427-2014: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K122389
Methodology: https://510kreport.com/methodology