# K200293: InMode System with vTone Applicator

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: May 5, 2020 after 90 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K891773 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081480: KEGEL8 Pelvic Exerciser, Model Oph 400, Ne Services, Ltd. (2008) Summary page 4.

## Indications for use
The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.

Source page: https://510kreport.com/device/K200293
Methodology: https://510kreport.com/methodology