# K191855: EmFace Device

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Oct 29, 2019 after 111 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: 21 generations back to K943450 (1995). 313 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153568: InMode Plus System, Inmode MD, Ltd. (2016) Summary page 4.

## Most influential descendants
- K242598: DEFINE System (AG612444A) (2024), 0 descendants of its own

## Indications for use
The EmFace Device with 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.

Source page: https://510kreport.com/device/K191855
Methodology: https://510kreport.com/methodology