# K201150: InMode RF Multi-System

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Jul 22, 2020 after 84 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 2 generations back to K171593 (2017). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182325: InMode RF System, Inmode MD, Ltd. (2018) Summary page 5.

## Most influential descendants
- K210492: InMode RF Pro System (2021), 7 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own
- K212253: Apollo Duet (Model : APD-4000) (2022), 1 descendant of its own
- K253261: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications: *Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. *WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. *BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Multi-System with the Fractional Applicators employs RF energy for various applications: *Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. *Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV *Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

Source page: https://510kreport.com/device/K201150
Methodology: https://510kreport.com/methodology