# K193355: Electrodes Handpieces for Mygen V-1000 RF System

- Pathway: 510(k) (Special)
- Applicant: RF Medical Co., Ltd.
- Decided: Aug 3, 2020 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: 1 generation back to K180999 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180999: Mygen V-1000 RF System, RF Medical Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K232763: Electrode Handpieces (VCT, RFTV, BMDT series) (2023), 0 descendants of its own

## Indications for use
Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.

Source page: https://510kreport.com/device/K193355
Methodology: https://510kreport.com/methodology