# K153568: InMode Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Jul 12, 2016 after 211 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: 20 generations back to K943450 (1995). 312 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 331 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150035: V10 system, Viora, Ltd. (2015) Summary page 4.

## Most influential descendants
- K172302: InMode PLUS System (2017), 13 descendants of its own
- K183450: EmBody System (2019), 8 descendants of its own
- 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
- K221571: InMode Multi-system (2022), 2 descendants of its own

## Indications for use
The InMode PLUS System with the PLUS/PLUS90 Hand pieces 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/K153568
Methodology: https://510kreport.com/methodology