# K181510: Echolaser X4

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Sep 4, 2018 after 88 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: 12 generations back to K943450 (1995). 143 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080959: Dornier Medilas D 30 Laser, Medilas D 1064, Dornier Medtech America, Inc. (2008) Summary page 4.

## Most influential descendants
- K213594: Echolaser X4 (2022), 1 descendant of its own
- K261964: Echolaser X4 (2026), 0 descendants of its own
- K260632: Laser Thermal Therapy Kit (2026), 0 descendants of its own

## Indications for use
The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

Source page: https://510kreport.com/device/K181510
Methodology: https://510kreport.com/methodology