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eagle laser surgical neodymium doped yttrium
Living Technology
Summary: The Eagle Laser Surgical Neodymium Doped Yttrium is a Class 2 medical device used primarily in surgical settings for precise tissue ablation and coagulation. It is utilized by surgeons across various specialties.
FDA Clearance Information
Pathway 510K
Number K893956 ↗
Decision Date August 10, 1989
Product Code GEX
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on August 10, 1989, by Living Technology. It is classified as a Class 2 device under product code GEX.
What It Is
The Eagle Laser Surgical Neodymium Doped Yttrium is a laser device used in surgical procedures to cut, ablate, or coagulate tissue. It operates by emitting a concentrated beam of light that can be precisely controlled, allowing for minimal damage to surrounding tissues. This makes it particularly useful in delicate surgeries where precision is paramount.
Clinical Applications
This device is commonly used in surgical specialties such as ophthalmology, dermatology, and oncology. In ophthalmology, it may be used for procedures like laser trabeculoplasty. Dermatologists might use it for removing skin lesions, while oncologists could employ it in tumor ablation. It is typically used in hospital operating rooms and specialized outpatient surgical centers.
Indications for Use
The FDA indications suggest that this device is intended for use in surgical procedures requiring precise cutting or coagulation of tissue. It is suitable for patients needing minimally invasive surgical interventions.
Practical Considerations
The device typically comes in various sizes to accommodate different surgical needs. It is compatible with standard surgical laser systems and requires specific training for safe and effective use. Proper eye protection is essential during operation to prevent accidental exposure.
Frequently Asked Questions
What is Eagle Laser Surgical Neodymium Doped Yttrium used for?
It is used for precise cutting, ablation, and coagulation of tissue in various surgical procedures.
What specialties typically use this device?
Specialties such as ophthalmology, dermatology, and oncology commonly use this device.
What are the FDA-cleared indications?
The device is indicated for surgical procedures requiring precise tissue cutting or coagulation.
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.