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Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers E…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K124003

by Med -fibers Inc.

Identifiers

510(k) Number
K124003 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 Med-Fibers Surgical Laser Fiber, Endo-ENT Laser Probes, and End- and Aspirating Laser Probes are flexible optical fibers and probes designed for laser-based surgical applications. These devices deliver laser energy for precise tissue ablation, coagulation, or vaporisation, commonly used in general and plastic surgery procedures.

These devices are supplied sterile and intended for single-use, as indicated by their FDA 510(k) clearance under the General, Plastic Surgery advisory committee. They are classified under product code GEX and comply with the Medical Device Directive (MDD). Storage and handling must adhere to sterile field protocols to maintain integrity prior to use.

Frequently asked questions

Are these laser fibers and probes designed for reuse, or are they intended for single-use only?

These devices are explicitly intended for single-use, as confirmed by their FDA 510(k) clearance under the General, Plastic Surgery advisory committee. The sterile packaging and surgical application context require adherence to sterile field protocols, reinforcing their disposable nature to prevent contamination and ensure patient safety.

What types of surgical procedures are these laser fibers and probes commonly used for?

The Med-Fibers devices are primarily designed for laser-based surgical applications in general and plastic surgery, enabling precise tissue ablation, coagulation, or vaporization. Their flexible design supports delicate procedures where targeted energy delivery is critical, such as in endoscopic or minimally invasive surgeries.

How should these laser fibers and probes be stored to maintain their sterility before use?

Since these devices are supplied sterile, storage must follow sterile field protocols to preserve their integrity. They should remain in their original packaging until immediately before use, and any handling should minimize exposure to contaminants. The manufacturer’s instructions (not provided here) should be consulted for specific storage conditions, but general sterile technique applies.

What regulatory pathways have these devices undergone, and what does that mean for their use?

These devices have received FDA 510(k) clearance under the General, Plastic Surgery advisory committee, demonstrating they are deemed substantially equivalent to a legally marketed predicate device. They also comply with the Medical Device Directive (MDD), indicating adherence to European regulatory standards if applicable. This clearance confirms their safety and effectiveness for the intended surgical laser applications.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Med -fibers Inc.
FDA Applicant
Med-Fibers, Inc.

Sources (2)

  • FDA 510(k) K124003 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026