# K200947: InMode System with the Morhpeus8 Applicators

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Jul 2, 2020 after 85 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: 20 generations back to K943450 (1995). 259 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192695: InMode System with the Morpheus8 (Fractora) Applicators, Inmode MD, Ltd. (2019) Summary page 4.

## Most influential descendants
- K231790: The InMode System with the Morpheus8 Applicators (2023), 10 descendants of its own
- K233642: InMode RF System (2024), 4 descendants of its own
- K240780: InMode RF System (2024), 3 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own

## Indications for use
The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora) Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K200947
Methodology: https://510kreport.com/methodology