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Sharplan Series 2900 Synthetic Contact TIPS
Sharplan Lasers
Summary: The Sharplan Series 2900 Synthetic Contact Tips are laser accessories used in surgical procedures to enhance precision and control. They are typically used by surgeons in specialties such as vascular surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K894211 ↗
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 510k pathway on August 10, 1989. Manufactured by Sharplan Lasers, this device is classified as Class 2 under the product code GEX.
What It Is
The Sharplan Series 2900 Synthetic Contact Tips are designed to be used with laser systems in surgical settings. These tips help focus the laser energy on targeted tissues, providing enhanced precision and control during procedures. They are particularly useful in procedures requiring meticulous dissection or ablation of tissues.
FDA-Cleared Indications
- Use as a synthetic contact tip with compatible Sharplan laser systems during surgical procedures.
- Use to apply laser energy through direct contact with targeted tissue when indicated by the compatible laser system's labeling.
Clinical Applications
- Contact delivery of laser energy during appropriately labeled surgical procedures.
- Precise tissue incision, dissection, or ablation when supported by the compatible laser system's indications for use.
Practical Considerations
- Confirm compatibility with the specific Sharplan Series 2900 laser system, wavelength, handpiece, and generator before use.
- Tip size and configuration should match the target tissue and procedure; the available FDA record does not specify the complete size range.
- Use requires training in the applicable surgical laser system, tissue effects, eye protection, plume control, and fire-safety precautions.
- MRI safety is not established in the available record. Do not bring the tip or connected laser equipment into the MRI environment unless its labeling specifically permits it.
- Inspect the tip before use and follow the manufacturer's instructions for sterility, cleaning, reuse, and disposal.
Frequently Asked Questions
What is Sharplan Series 2900 Synthetic Contact Tips used for?
These tips are used to enhance precision and control in laser-assisted surgical procedures, particularly in vascular surgeries.
What specialties typically use this device?
Specialties such as vascular surgery, dermatology, and ophthalmology commonly use these contact tips.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein and other vascular structures, where precise laser application is needed.
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.