Echolaser X4
by El.En Electronic Engineering Spa EUDAMED510(k)
Active
510(k) K181510
Overview
The Echolaser X4 is a medical device classified as a laser system for tissue ablation and coagulation, designed for use in general and plastic surgery procedures. It delivers controlled laser energy to achieve precise tissue effects, including vaporisation, incision, and haemostasis, with adjustable parameters to suit clinical requirements.
This device is supplied as a reusable, non-sterile system intended for use in operating rooms or clinical settings where sterile conditions can be maintained. It operates within MRI-safe parameters for the specified settings and is authorised under FDA 510K clearance (K181510) and MDR compliance. Storage and handling follow manufacturer guidelines to ensure operational integrity, with no single-use components specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK181510 | Date4 Sep 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from El.En Electronic Engineering Spa
Questions
What types of surgical procedures is the Echolaser X4 primarily intended for, and how does it achieve its effects?
The Echolaser X4 is designed for general and plastic surgery procedures, where it delivers controlled laser energy to perform precise tissue ablation and coagulation. It achieves effects like vaporisation, incision, and haemostasis by adjusting parameters to meet clinical needs, ensuring targeted tissue modification without invasive tools.
Is the Echolaser X4 a single-use or reusable device, and what does this mean for my clinical workflow?
The Echolaser X4 is a reusable system, meaning it is not discarded after a single use. This allows for cost efficiency and repeated use in sterile operating room environments, provided proper cleaning, maintenance, and sterilisation protocols are followed as per the manufacturer’s guidelines.
How should the Echolaser X4 be stored, and are there any special considerations for maintaining its functionality?
The Echolaser X4 must be stored and handled according to the manufacturer’s instructions to preserve its operational integrity. Since it is non-sterile and reusable, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. No single-use components are specified, so maintenance focuses on the reusable system itself.
Can the Echolaser X4 be used in an MRI environment, and if so, under what conditions?
Yes, the Echolaser X4 is designed to operate within MRI-safe parameters for the specified settings. However, its use must strictly adhere to the manufacturer’s guidelines to ensure compatibility and safety within an MRI facility, as parameters may vary based on clinical setup and imaging requirements.
What regulatory pathways has the Echolaser X4 followed, and how does this affect its availability?
The Echolaser X4 has obtained FDA 510K clearance (K181510) under a traditional review process, demonstrating substantial equivalence to a predicate device. It also complies with the EU’s Medical Device Regulation (MDR). These approvals confirm its market availability in the U.S. and EU, ensuring it meets regulatory standards for safety and performance in surgical applications.