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sharplan series 2900 synthetic contact tips
Sharplan Lasers
Summary: The Sharplan Series 2900 Synthetic Contact Tips are used in laser surgery to enhance precision and control. They are primarily utilized by surgeons in specialties such as vascular surgery and interventional radiology.
FDA Clearance Information
Pathway 510K
Number K894210 ↗
Decision Date August 10, 1989
Product Code GEX
Device Class Class 2
Evidence 0 studies
The Sharplan Series 2900 Synthetic Contact Tips were cleared through the FDA 510(k) pathway on August 10, 1989. Manufactured by Sharplan Lasers, this device is classified as a Class 2 medical device.
What It Is
The Sharplan Series 2900 Synthetic Contact Tips are designed to be used with laser systems to improve the accuracy and efficacy of laser-based procedures. These tips are synthetic, allowing for consistent performance and reduced risk of contamination. They are typically attached to the laser handpiece, providing a precise point of contact with the tissue.
Clinical Applications
These contact tips are commonly used in procedures involving the portal vein, where precision is crucial. They are often employed in vascular surgeries and interventional radiology to target specific tissues while minimizing damage to surrounding areas. The device is suitable for use in both hospital and outpatient surgical settings, catering to adult and pediatric patient populations.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving the portal vein. Clinically, this means it is suitable for surgeries requiring precise laser application in vascular areas, particularly where the portal vein is involved.
Practical Considerations
The Sharplan Series 2900 tips come in various sizes to accommodate different surgical needs and are compatible with a range of laser systems. Clinicians should ensure proper attachment to the laser handpiece and follow recommended sterilization protocols to maintain device integrity.
Frequently Asked Questions
What is the Sharplan Series 2900 Synthetic Contact Tips used for?
They are used to enhance precision and control in laser surgeries, particularly in procedures involving the portal vein.
What specialties typically use this device?
Specialties such as vascular surgery and interventional radiology commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, requiring precise laser application.
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.