đź“‹ FDA Reference
slt select fiber delivery system and contact tips
Surgical Laser Technologies
Summary: The SLT Select Fiber Delivery System is a medical device used for laser-based procedures, primarily in vascular applications. It is typically used by surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K980156 ↗
Decision Date
February 27, 1998
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The SLT Select Fiber Delivery System was cleared by the FDA via the 510k pathway on February 27, 1998. It is manufactured by Surgical Laser Technologies and is classified as a Class 2 device.
What It Is
The SLT Select Fiber Delivery System is a laser fiber delivery device designed for precise energy delivery during surgical procedures. It utilizes specialized contact tips to focus laser energy on targeted tissues, allowing for controlled ablation or coagulation. This system is particularly useful in procedures requiring precise control over tissue interaction, such as in vascular surgeries.
Clinical Applications
This device is commonly used in vascular surgery and interventional radiology settings, particularly for procedures involving the portal vein. It is suitable for use in hospitals and surgical centers, where precise laser application is required. The patient population typically includes those with vascular conditions that benefit from laser treatment, such as varicose veins or other vascular abnormalities.
Indications for Use
The FDA indications suggest this device is intended for use in procedures involving the portal vein, likely for conditions that require precise laser intervention. It is suitable for patients needing vascular laser treatment.
Practical Considerations
The device requires compatibility with specific laser systems, and clinicians should ensure the correct sizing of fiber tips for their specific procedure. Proper technique is crucial to maximize the effectiveness and safety of the laser application.
Frequently Asked Questions
What is the SLT Select Fiber Delivery System used for?
It is used for precise laser delivery in vascular procedures, particularly involving the portal vein.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures involving the portal vein, requiring precise laser intervention.
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.