# K130689: Symphony RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Thermigen, Inc.
- Decided: Nov 15, 2013 after 247 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: 17 generations back to K943450 (1995). 103 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975, Smith & Nephew, Inc. (2004) Summary page 2.
- K000944: Thermage Thermacool System, Thermage, Inc. (2000) Summary page 2.
- K082834: Ellman International Non-Ablative Technique for Surgitron  Iec, Ellman Int'L, Inc. (2009) Summary page 2.
- K102368: Non-Ablative Wrinkle Treatment Handpiece, Ellman Int'L, Inc. (2010) Summary page 2.

## Most influential descendants
- K171094: Thermi Reusable Non-invasive RF Electrode (2017), 6 descendants of its own
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own
- K161661: Thermi RF Accessories (2016), 3 descendants of its own
- K170116: Thermi Injectable RF Electrodes (2017), 2 descendants of its own
- K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (2025), 1 descendant of its own

## Indications for use
The ThermiGen Symphony RE Generator System and the probes that are used with it are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. To create lesions in nervous tissue when wsed in combination with Neuromhermn (previously Smith&Nephew) thermal/coagulation probes.

Source page: https://510kreport.com/device/K130689
Methodology: https://510kreport.com/methodology