# K183450: EmBody System

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Jun 20, 2019 after 190 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). 315 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 324 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.
- K172302: InMode PLUS System, Inmode MD, Ltd. (2017) Summary page 4.

## Most influential descendants
- K201285: InMode Evolve System with the Tone Applicator (2021), 6 descendants of its own
- K210877: Evolve System with the T3 Applicator (2021), 5 descendants of its own
- K241433: EVE Synergy (EVE-20M) (2025), 1 descendant of its own
- K253542: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own
- K240992: eMVFit (MVF-10M) (2024), 0 descendants of its own

## Indications for use
The InMode EmBody System with its designated hand pieces is intended for the treatment of the following medical conditions; The EmBodyPLUS hand piece is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The EmBodyFX Hand piece is intended for the treatment of the following medical conditions using 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/K183450
Methodology: https://510kreport.com/methodology