# K213594: Echolaser X4

- Pathway: 510(k) (Traditional)
- Applicant: Elesta S.P.A
- Decided: May 3, 2022 after 172 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
Longest line of descent: 13 generations back to K943450 (1995). 144 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181510: Echolaser X4, El.En Electronic Engineering Spa (2018) Summary page 4.

## Most influential descendants
- K261964: Echolaser X4 (2026), 0 descendants of its own

## Indications for use
The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064 nm.

Source page: https://510kreport.com/device/K213594
Methodology: https://510kreport.com/methodology