# K192695: InMode System with the Morpheus8 (Fractora) Applicators

- Pathway: 510(k) (Special)
- Applicant: Inmode MD, Ltd.
- Decided: Dec 27, 2019 after 92 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: 19 generations back to K943450 (1995). 258 ancestors in all.
16 later devices descend from it; 1 cites 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)
- K180189: InMode System with Fractora3D/3D-90 Applicators, Inmode MD, Ltd. (2018) Summary page 4.

## Most influential descendants
- K200947: InMode System with the Morhpeus8 Applicators (2020), 15 descendants of its own
- 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

## Indications for use
The InMode System with the Morpheus8 (Fractora) Applicators is mtended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis. At higher energy levels greater than 62 mlJ/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K192695
Methodology: https://510kreport.com/methodology