# K253484: Lutronic Genius

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure Lutronic Technology Corporation
- Decided: Jun 29, 2026 after 255 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: 22 generations back to K943450 (1995). 264 ancestors in all.
No later device cites it as a predicate yet.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180945: LUTRONIC GENIUS Radiofrequency System, Lutronic Corporation (2018) Summary page 5.
- K231790: The InMode System with the Morpheus8 Applicators, InMode, Ltd. (2023) Summary page 5.

## Indications for use
The LUTRONIC GENIUS is intended for use in dermatologic and general surgical procedures for electrocoagulation/contraction and hemostasis.

Source page: https://510kreport.com/device/K253484
Methodology: https://510kreport.com/methodology