# K213612: Sylfirm X

- Pathway: 510(k) (Traditional)
- Applicant: VIOL Co., Ltd.
- Decided: Jun 23, 2022 after 220 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: 13 generations back to K943450 (1995). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200185: Sylfirm X, VIOL Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K243097: RM STAR EX with RMS Needle (2024), 0 descendants of its own

## Indications for use
The SYLFIRM XrM is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K213612
Methodology: https://510kreport.com/methodology