# K240017: InMode System with the Morpheus8 90 Applicator

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Jun 13, 2024 after 163 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.
No later device cites it as a predicate yet.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180189: InMode System with Fractora3D/3D-90 Applicators, Inmode MD, Ltd. (2018) Summary page 4.
- K200947: InMode System with the Morhpeus8 Applicators, InMode, Ltd. (2020) Summary page 4.

## Indications for use
The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological 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 90 Applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K240017
Methodology: https://510kreport.com/methodology