# K231790: The InMode System with the Morpheus8 Applicators

- Pathway: 510(k) (Special)
- Applicant: InMode, Ltd.
- Decided: Jul 20, 2023 after 30 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: 21 generations back to K943450 (1995). 260 ancestors in all.
10 later devices descend from it; 7 cite it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200947: InMode System with the Morhpeus8 Applicators, InMode, Ltd. (2020) Summary page 4.

## Most influential descendants
- K233642: InMode RF System (2024), 4 descendants of its own
- K240780: InMode RF System (2024), 3 descendants of its own
- K251632: Optimas MAX System (2025), 1 descendant of its own
- K253484: Lutronic Genius (2026), 0 descendants of its own
- K251435: InbellaIgnite RF System (2026), 0 descendants of its own

## Indications for use
The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K231790
Methodology: https://510kreport.com/methodology