Identifiers
- 510(k) Number
- K152591 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 RFID Laser Fibers are accessories designed for use with the Dornier Medilas H Holmium Laser. These fibers facilitate the cutting, vaporization, ablation, and coagulation of soft tissue during open surgery or when used in conjunction with endoscopic equipment such as laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes.
This device is cleared under FDA 510(k) K152591. The fibers are intended for clinical applications as specified in the device documentation.
Frequently asked questions
What are Medilas H RFID Laser Fibers used for?
These fibers are designed to facilitate the cutting, vaporization, ablation, and coagulation of soft tissue. They are intended for use during open surgery or in conjunction with endoscopic equipment, including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes.
Which laser systems are compatible with these fibers?
The Medilas H RFID Laser Fibers are specifically designed for use with the Dornier Medilas H Holmium Laser system.
What is the regulatory status of this device?
The Medilas H RFID Laser Fibers have been cleared by the FDA under 510(k) number K152591, having been determined to be substantially equivalent to existing devices.
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, Dornier MedTech - A Leading Urological Medical Device Company, Medilas H RFID Laser Fibers (K152591) — FDA 510(k) | Innolitics, MEDILAS H LASER FIBERS (K123385) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152591 | Class II | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA 510(k) K152591 24 fields · synced Oct 6, 2026