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surgical laser micro-tips
Surgical Laser Technologies
Summary: Surgical laser micro-tips are precision tools used in various surgical procedures to enhance accuracy and reduce tissue damage. They are typically used by surgeons in specialties such as periodontics and vascular surgery.
FDA Clearance Information
Pathway
510K
Number
K844644 ↗
Decision Date
May 10, 1985
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The surgical laser micro-tips by Surgical Laser Technologies were cleared through the FDA 510(k) pathway on May 10, 1985. This device is classified as Class II under product code GEX.
What It Is
Surgical laser micro-tips are specialized attachments for surgical lasers, designed to focus laser energy onto small, precise areas. These tips allow for minimally invasive procedures by providing surgeons with enhanced control and precision. They are often used in conjunction with Nd:YAG or diode lasers, which are known for their ability to cut, coagulate, and vaporize tissue with minimal collateral damage.
Clinical Applications
These micro-tips are commonly used in periodontics for procedures such as the Laser Assisted New Attachment Procedure (LANAP), which targets periodontal disease. They are also utilized in vascular surgeries, particularly in procedures involving the portal vein, where precision is crucial. The device is suitable for use in both hospital and outpatient settings, catering to adult patients with specific surgical needs.
Indications for Use
The FDA indications suggest that these micro-tips are intended for use in surgical procedures requiring precise laser application. This includes treatments for periodontal disease and other conditions where tissue precision is paramount.
Practical Considerations
Surgical laser micro-tips come in various sizes to accommodate different surgical needs and are compatible with standard laser systems like Nd:YAG and diode lasers. Surgeons should be trained in laser safety and technique to optimize outcomes and minimize risks.
Related Literature
The linked study compared the effectiveness of Nd:YAG and diode lasers in the Laser Assisted New Attachment Procedure (LANAP) for managing Stage II periodontitis. While the abstract is not available, such studies typically focus on evaluating clinical outcomes like attachment gain and pocket depth reduction. Limitations may include sample size and lack of long-term follow-up.
Frequently Asked Questions
What is surgical laser micro-tips used for?
They are used for precision surgical procedures, particularly in periodontics and vascular surgeries, to enhance accuracy and reduce tissue damage.
What specialties typically use this device?
Periodontists and vascular surgeons commonly use these micro-tips in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in surgical procedures requiring precise laser application, such as periodontal treatments and vascular surgeries.
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.