← Back to catalogue

Dornier Medilas Uropulse

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130344

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K130344 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medilas H Uropulse is a holmium laser system (Product Code: GEX) designed for lithotripsy and soft tissue applications in urological procedures. It operates at a power output of 20 watts, delivering high-energy pulses for the fragmentation of urinary stones and precise tissue ablation.

This device is supplied as a reusable medical system, intended for use in clinical settings such as operating rooms or urology suites. It features a graphical user interface for adjustable energy and frequency settings, ensuring adaptability to various procedural requirements. The Medilas H Uropulse holds FDA 510(k) clearance under Special Review (K130344) and is manufactured by Dornier MedTech America, Inc.

Frequently asked questions

What types of urological procedures is the Dornier Medilas Uropulse primarily designed for, and how does it differ from other laser systems in this category?

The Dornier Medilas Uropulse is specifically designed for lithotripsy (breaking down urinary stones) and soft tissue ablation in urological procedures. Unlike some laser systems that may focus solely on stone fragmentation, this device also offers precise tissue ablation, making it versatile for procedures like tumor resection or prostate surgery. Its 20-watt power output and adjustable energy/frequency settings via a graphical user interface allow clinicians to tailor treatment to different stone types or tissue densities, enhancing adaptability for complex cases.

Is the Dornier Medilas Uropulse a single-use or reusable device, and what does that mean for my clinical workflow?

The Dornier Medilas Uropulse is a reusable medical system, meaning it is built for repeated use in clinical settings like operating rooms or urology suites. This design reduces waste and operational costs compared to single-use devices, but it requires adherence to manufacturer-provided maintenance protocols (e.g., cleaning, sterilization) to ensure safety and performance. Reusability also means it can be integrated into existing workflows without requiring additional disposal steps.

How does the device’s regulatory pathway (e.g., FDA clearance) impact its use in my facility?

The Dornier Medilas Uropulse holds FDA 510(k) clearance under Special Review (K130344), which means it has been deemed *substantially equivalent* to a legally marketed predicate device. This clearance confirms the device meets U.S. safety and effectiveness standards for its intended uses (lithotripsy and soft tissue applications). While clearance doesn’t guarantee clinical outcomes, it provides assurance that the device adheres to regulatory requirements for its specified applications, simplifying procurement and compliance for your facility.

What should I consider when storing or preparing the Dornier Medilas Uropulse for use, given it’s a reusable system?

Since the Medilas Uropulse is reusable, proper storage and preparation are critical to maintain performance and sterility. The manufacturer’s instructions (not provided here) will outline specific protocols, but generally, this involves cleaning after each use, sterilizing components as required (e.g., autoclave or chemical sterilization), and storing in a clean, dry environment to prevent contamination or damage. Always follow the provided user manual to avoid voiding warranty or compromising safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medilas H Uropulse — Dornier MedTech Americas, Laser Stone Management — Dornier MedTech, PDF Medilas H UroPulse-Brochure - Amazon Web Services, PDF Dornier Medilas H Uropulsetm Convenient Stone Management

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K130344 24 fields · synced Oct 6, 2026