# K213557: Finexel

- Pathway: 510(k) (Traditional)
- Applicant: SNJ Co., Ltd.
- Decided: Apr 12, 2022 after 155 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231514: Azure (2024), 0 descendants of its own

## Indications for use
Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

Source page: https://510kreport.com/device/K213557
Methodology: https://510kreport.com/methodology