đź“‹ FDA Reference
the alma opus system colibri applicator and tips
Alma Lasers
Summary: The Alma Opus System Colibri Applicator is a medical device used for minimally invasive procedures involving the portal vein. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K201520 ↗
Decision Date
October 27, 2021
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Alma Opus System Colibri Applicator, manufactured by Alma Lasers, received FDA clearance through the 510(k) pathway on October 27, 2021. It is classified as a Class 2 device under product code GEI.
What It Is
The Alma Opus System Colibri Applicator is a specialized medical device designed for procedures involving the portal vein. It utilizes advanced laser technology to assist in minimally invasive interventions. The device is engineered to provide precision and control, enhancing the safety and efficacy of portal vein procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful for procedures that require access to the portal vein, such as portal vein embolization or treatment of portal hypertension. The device is suitable for adult patients who require these specialized interventions.
Indications for Use
The FDA has cleared this device for use in procedures involving the portal vein. It is indicated for patients who need interventions that require precise access and treatment within the portal venous system.
Practical Considerations
The Alma Opus System Colibri Applicator is compatible with standard interventional radiology equipment. Clinicians should be familiar with laser safety protocols and ensure proper calibration before use. The device's design allows for easy integration into existing procedural workflows.
Frequently Asked Questions
What is the Alma Opus System Colibri Applicator used for?
It is used for minimally invasive procedures involving the portal vein, such as embolization or treatment of portal hypertension.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for procedures involving the portal vein, providing precise access and treatment within the portal venous system.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.