# K180945: LUTRONIC GENIUS Radiofrequency System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Dec 10, 2018 after 243 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: 11 generations back to K943450 (1995). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 4.

## Most influential descendants
- K253484: Lutronic Genius (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K180945
Methodology: https://510kreport.com/methodology