# K173582: ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Thermigen, L.L.C
- Decided: Jan 17, 2018 after 58 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: 20 generations back to K943450 (1995). 107 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130689: Symphony RF Generator, Thermigen, Inc. (2013) Summary page 4.
- K171094: Thermi Reusable Non-invasive RF Electrode, Thermgen, L.L.C (2017) Summary page 4.
- K170116: Thermi Injectable RF Electrodes, Thermi (2017) Summary page 4.

## Most influential descendants
- K222709: Retraction, CWM-910T, APOLEX Tite (2023), 0 descendants of its own

## Indications for use
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) are indicated: - for use in dermatological and general surgical procedures for electrocoagulation and hemostasis - to create lesions in nervous tissue

Source page: https://510kreport.com/device/K173582
Methodology: https://510kreport.com/methodology