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Dornier Medila H

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983963

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K983963 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 Dornier Medilas H is a holmium laser system designed for urological procedures, specifically for tissue ablation, resection, and lithotripsy. As a high-power laser, it delivers precise energy for cutting and vaporising tissue while minimising thermal damage. Its application spans stone fragmentation, prostatectomy, and other minimally invasive urological surgeries. The device operates within the holmium wavelength range, optimised for soft tissue and calculus treatment.

The Dornier Medilas H is supplied as a reusable medical device, intended for use in clinical settings such as operating rooms and urology suites. It requires proper maintenance, including cleaning and calibration, as outlined in the service manual. The system is not indicated for MRI environments and must be stored in a controlled environment to ensure operational integrity. Authorised for use in the United States under FDA 510(k) clearance (K983963), it adheres to regulatory standards for urological laser devices. No additional sterility claims are specified beyond standard surgical instrument protocols.

Frequently asked questions

What is the Dornier Medilas H holmium laser system used for?

The Dornier Medilas H is a holmium laser system specifically designed for urological surgeries. It delivers precise energy for cutting and vaporising tissue, making it ideal for procedures like stone fragmentation (lithotripsy), prostatectomy, and other minimally invasive urological interventions. Its holmium wavelength is optimised for soft tissue and calculus treatment, reducing thermal damage to surrounding areas.

Is the Dornier Medilas H a single-use or reusable device?

The Dornier Medilas H is a reusable medical device. It is intended for use in clinical settings such as operating rooms and urology suites, where it requires regular maintenance, including cleaning and calibration as outlined in the service manual. Reusability ensures cost-effectiveness and operational efficiency in controlled environments.

What storage conditions are required for the Dornier Medilas H?

The Dornier Medilas H must be stored in a controlled environment to maintain its operational integrity. This includes protection from environmental factors that could compromise its performance. The device is not intended for use in MRI environments, so storage should avoid areas with magnetic interference or electromagnetic fields.

Does the Dornier Medilas H have any special sterility requirements?

The device does not claim specific sterility beyond standard surgical instrument protocols. Since it is reusable, proper cleaning and maintenance procedures must be followed to ensure hygiene and prevent contamination between uses. Always adhere to the manufacturer’s guidelines for disinfection and sterilisation.

What regulatory approval does the Dornier Medilas H hold?

The Dornier Medilas H is authorised for use in the United States under FDA 510(k) clearance with the reference number K983963. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for urological laser systems.

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: PDF Dornier Medilas H 140, Bringing Power to Perfection — Dornier MedTech Americas, DORNIER MEDILAS H SERVICE MANUAL Pdf Download | ManualsLib, Dornier MedTech - A Leading Urological Medical Device Company, Dornier Medilas H Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K983963 24 fields · synced Oct 5, 2026