# K221407: truSculpt iD

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Jul 13, 2022 after 58 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 20 generations back to K943450 (1995). 111 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172004: truSculpt, Cutera, Inc. (2017) Summary page 4.
- K180709: truSculpt RF Device; truSculpt; truSculpt 3D, Cutera, Inc. (2018) Summary page 4.

## Most influential descendants
- K223110: truSculpt iD (2022), 1 descendant of its own
- K252888: NeoSculpt Plus (2026), 0 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 and muscle spasms and increase in local circulation. Additionally, the 2MHz setting for the 40cm2 handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K221407
Methodology: https://510kreport.com/methodology