# K201285: InMode Evolve System with the Tone Applicator

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Mar 5, 2021 after 296 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 322 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192249: InMode System with Tone Applicator, InMode, Ltd. (2019) Summary page 4.
- K183450: EmBody System, Inmode MD, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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
- K230167: BACK 4 (2023), 0 descendants of its own

## Indications for use
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas. The EVOLVE System with Tone Applicator is designed to operate in two modes — EMS and TENS. In EMS mode it is used for: » Relaxation of muscle spasms * Prevention or retardation of disuse atrophy » Increasing local blood circulation * Muscle re-education * Maintaining or increasing range of motion » Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode is intended for » Symptomatic relief and management of chronic, intractable pain * Post-surgical acute pain * Post-trauma acute pain

Source page: https://510kreport.com/device/K201285
Methodology: https://510kreport.com/methodology