# K160329: InMode System MiniFX Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Aug 19, 2016 after 196 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: 17 generations back to K943450 (1995). 66 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131362: Inmode Wmbody Device, Inmode MD, Ltd. (2013) Summary page 4.

## Most influential descendants
- K170637: sensiFirm (2017), 3 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own
- K181095: RF-Relief (2018), 1 descendant of its own
- K250734: OptiLUV Device (2025), 0 descendants of its own

## Indications for use
The InMode System with the WMbody Handpiece and the MiniFX Handpiece is intended for the treatment of the following medical conditions using non thermal RF combined with massage: Relief of' minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K160329
Methodology: https://510kreport.com/methodology