# K180189: InMode System with Fractora3D/3D-90 Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Inmode MD, Ltd.
- Decided: Jun 1, 2018 after 129 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: 18 generations back to K943450 (1995). 257 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 296 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130501: Intensif, Endymed Medical, Ltd. (2014) Summary page 4.

## Most influential descendants
- K192545: Potenza (2020), 20 descendants of its own
- K192695: InMode System with the Morpheus8 (Fractora) Applicators (2019), 16 descendants of its own
- 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
- K201685: Potenza (2021), 9 descendants of its own

## Indications for use
The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis. At higher energy levels greater than 62 mJ/pin, use of the FRF applicator is limited to Skin Types I-IV.

Source page: https://510kreport.com/device/K180189
Methodology: https://510kreport.com/methodology