📋 FDA Reference
Eagle - Neodyumium Doped Yttrium Aluminum Garnet
Living Technology
Summary: The Eagle is a neodymium-doped yttrium aluminum garnet laser device used in medical procedures, particularly in interventional radiology for y90-radioembolization. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K885257 ↗
Decision Date ?
June 5, 1989
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Eagle device was cleared through the FDA 510k pathway on June 5, 1989. Manufactured by Living Technology, it is classified as a Class 2 medical device under product code GEX.
What It Is
The Eagle is a laser device that utilizes neodymium-doped yttrium aluminum garnet (Nd:YAG) technology. It emits a specific wavelength of light that can be used to target tissues with precision. This type of laser is commonly used in medical settings for its ability to deliver controlled energy to specific areas, making it valuable in procedures that require precision and minimal invasiveness.
FDA-Cleared Indications
- Use as a medical laser for controlled delivery of Nd:YAG laser energy during procedures requiring precise tissue targeting.
- Use in medical procedures where focused laser energy is applied to selected tissue under appropriate clinical supervision.
Clinical Applications
- Delivery of controlled laser energy during image-guided interventional procedures.
- Use by trained hospital-based specialists when precise tissue targeting is required.
- Use in clinical workflows associated with Y-90 radioembolization, when consistent with the device labeling and institutional protocol.
Practical Considerations
- The available record does not provide the laser wavelength, output-power range, fiber dimensions, or other model-specific specifications; these should be confirmed in the FDA labeling and manufacturer documentation.
- Laser safety precautions are required, including controlled access, appropriate protective eyewear, warning signage, and trained staff.
- The device should be calibrated, inspected, and operated according to the manufacturer’s instructions and institutional laser-safety policy.
- Compatibility with catheters, fibers, imaging systems, and other interventional equipment must be verified before use.
- MRI compatibility is not established in the available record. Do not bring the device or its accessories into the MRI environment unless the specific component is labeled MR Safe or MR Conditional.
Procedures that use this device
Frequently Asked Questions
What is Eagle used for?
The Eagle is used for precise tissue targeting in medical procedures, such as y90-radioembolization for liver tumors.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for procedures requiring precise tissue targeting, particularly in treating liver tumors with y90-radioembolization.
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.