# K242598: DEFINE System (AG612444A)

- Pathway: 510(k) (Special)
- Applicant: InMode, Ltd.
- Decided: Nov 14, 2024 after 76 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: 22 generations back to K943450 (1995). 363 ancestors in all.
No later device cites it as a predicate yet.
0 of 364 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191855: EmFace Device, Inmode MD, Ltd. (2019) Summary page 5.
- K210492: InMode RF Pro System, Inmode MD, Ltd. (2021) Summary page 5.
- K231790: The InMode System with the Morpheus8 Applicators, InMode, Ltd. (2023) Summary page 5.

## Indications for use
The DEFINE System with the non-invasive applicators employs RF energy for various applications: The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, and for the temporary improvement of local blood circulation. The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite. The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K242598
Methodology: https://510kreport.com/methodology