đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Intended for use with compatible laser systems for procedures involving the portal vein.
- Used as a synthetic contact tip to deliver controlled laser energy at the tissue-treatment site.
Clinical Applications
- Laser application involving the portal vein.
- Contact laser treatment in vascular surgical procedures when performed with the compatible Sharplan laser system.
- Use by trained surgical teams in hospital or outpatient operating-room settings according to the device and laser-system labeling.
Practical Considerations
- Compatibility must be confirmed with the specific Sharplan Series 2900 laser system, handpiece and tip size before use.
- The record indicates synthetic contact tips, but the available information does not establish a complete list of tip sizes; clinicians should consult the original device labeling.
- Use requires appropriate laser safety controls, including trained personnel, protective eyewear and management of ignition or thermal hazards.
- Sterilization, reuse and handling requirements should follow the manufacturer's instructions; incorrect processing can damage the tip or affect performance.
- MRI safety is not established in the available FDA record. Do not assume the tip is MRI safe or MR conditional without current manufacturer documentation.
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.