# K210877: Evolve System with the T3 Applicator

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Jul 19, 2021 after 117 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: 24 generations back to K943450 (1995). 323 ancestors in all.
5 later devices descend from it; 5 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)
- K201285: InMode Evolve System with the Tone Applicator, InMode, Ltd. (2021) Summary page 5.
- K183450: EmBody System, Inmode MD, Ltd. (2019) Summary page 5.

## Most influential descendants
- 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
- K230037: BACK 3 (2023), 0 descendants of its own

## Indications for use
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode 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 T3 Applicator in EMS mode is intended 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 The T3 Applicator in TENS mode is intended for: » Symptomatic relief and management of chronic, intractable pain * Post-surgical acute pain * Post-trauma acute pain The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

Source page: https://510kreport.com/device/K210877
Methodology: https://510kreport.com/methodology