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Medilas H Laser Fibers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123385

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K123385 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)

Medilas H Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser. This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes.

The device is supplied as a reusable laser fiber and is authorized under FDA 510(k) clearance K123385. It is manufactured by Dornier MedTech America, Inc. and is intended for use in clinical settings with compatible endoscopic systems.

Frequently asked questions

What is the intended use of the Medilas H Laser Fibers?

The Medilas H Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser to cut, vaporize, ablate, and coagulate soft tissue in conjunction with endoscopic equipment such as laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes.

Is the Medilas H Laser Fiber reusable or single-use?

The Medilas H Laser Fiber is supplied as a reusable device, meaning it can be cleaned, sterilized, and used multiple times in accordance with the manufacturer's reprocessing instructions and institutional protocols.

What regulatory authorization does the Medilas H Laser Fiber have?

The Medilas H Laser Fiber is authorized under FDA 510(k) clearance K123385, which confirms its substantial equivalence to a legally marketed predicate device for the intended use as an accessory to the Holmium laser system.

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: Lasers & Fibers — Dornier MedTech Americas, PDF Dornier Medilas H 140, DORNIER MEDILAS H SERVICE MANUAL Pdf Download | ManualsLib, MEDILAS H LASER FIBERS (K123385) — FDA 510(k) | Innolitics, Dornier Medilas-H-100 Brochure | PDF | Laser - Scribd

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) K123385 24 fields · synced Oct 6, 2026