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OmniGuide Sterile Waveguide Adapter System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073409

by Omniguide, Inc.

Identifiers

510(k) Number
K073409 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 OmniGuide Sterile Waveguide Adapter System is a laser waveguide adapter designed to connect a CO₂ laser to OmniGuide WaveGuide fibers. It facilitates the delivery of laser energy for soft tissue procedures, including incision, excision, ablation, vaporization, and coagulation, in sterile surgical environments. The device integrates with existing CO₂ laser systems to enhance precision and control during minimally invasive procedures. Its construction enables compatibility with autoclave sterilization, ensuring repeated use in clinical settings.

This system is supplied as a reusable medical device, requiring autoclave sterilization between uses. The output tube and gas hose are provided non-sterile, allowing hospitals to sterilize them prior to surgical application. The adapter is classified under FDA product code GEX and falls under the General, Plastic Surgery advisory committee category. It adheres to regulatory standards for laser-related devices, ensuring compliance with FDA 510(k) clearance (K073409) and Traditional clearance type for Class II devices.

Frequently asked questions

What is the OmniGuide Sterile Waveguide Adapter System used for?

The OmniGuide Sterile Waveguide Adapter System connects a CO₂ laser to OmniGuide WaveGuide fibers, delivering laser energy for soft tissue procedures. It supports incision, excision, ablation, vaporization, and coagulation in sterile surgical settings, enhancing precision and control during minimally invasive operations.

How is the OmniGuide Sterile Waveguide Adapter System supplied?

The system is supplied as a reusable medical device. The adapter itself is designed for autoclave sterilization between uses, while the output tube and gas hose are provided non-sterile. Hospitals can sterilize these components prior to surgical application.

Can the adapter be reused after sterilization?

Yes, the adapter is constructed for repeated use in clinical settings. It is compatible with autoclave sterilization, allowing hospitals to maintain sterility between procedures. This ensures compliance with surgical standards while extending the device’s lifespan.

What regulatory approval does the OmniGuide Sterile Waveguide Adapter System hold?

The device holds FDA 510(k) clearance under the classification of General, Plastic Surgery (product code GEX). It was granted Traditional clearance as a Class II device, ensuring it meets regulatory standards for laser-related medical applications.

How does the adapter integrate with existing CO₂ laser systems?

The OmniGuide Sterile Waveguide Adapter System is designed to seamlessly connect to existing CO₂ laser systems, enabling the precise delivery of laser energy through OmniGuide WaveGuide fibers. This integration enhances surgical control and accuracy during procedures.

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: OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM (K073409) — FDA 510 (k ..., PDF 510(k) Summary - accessdata.fda.gov, Omniguide Sterile Waveguide Adapter System - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Omniguide, Inc.

Sources (1)

  • FDA 510(k) K073409 24 fields · synced Oct 1, 2026