đź“‹ FDA Reference
Living Technology Laser Contact TIPS
Living Technology
Summary: The Living Technology Laser Contact Tips are used in laser surgeries to enhance precision and control. They are typically utilized by surgeons in various specialties, including vascular and general surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K884682 ↗
Decision Date ?
January 5, 1989
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Living Technology Laser Contact Tips were cleared through the FDA 510k pathway on January 5, 1989. Manufactured by Living Technology, this device is classified as Class 2 under product code GEX.
What It Is
The Living Technology Laser Contact Tips are specialized attachments for laser surgical devices, designed to focus and direct laser energy precisely. These tips are used to improve the accuracy and effectiveness of laser procedures by providing a controlled point of contact. This technology is particularly useful in surgeries requiring high precision, such as those involving delicate vascular structures.
FDA-Cleared Indications
- Use with compatible surgical laser systems for procedures involving the portal vein.
- Use for procedures involving related vascular structures when the contact tip is compatible with the laser system and the labeled application.
Clinical Applications
- Contact laser procedures involving the portal vein.
- Contact laser procedures involving related vascular structures.
- Laser surgery requiring a controlled point of contact with tissue, when performed within the device labeling and compatible laser-system instructions.
Practical Considerations
- Confirm compatibility with the specific surgical laser system, handpiece, wavelength and connector before use.
- Select the tip size and configuration specified for the procedure and target anatomy.
- Follow the manufacturer’s instructions for attachment, calibration, sterilization or single-use handling, as applicable.
- The FDA record does not establish MRI safety; MRI use should be avoided unless the specific tip and complete laser system are labeled MR Safe or MR Conditional.
- Laser procedures require appropriate eye protection, control of the laser field and precautions for thermal or mechanical injury to adjacent tissue.
Frequently Asked Questions
What is Living Technology Laser Contact Tips used for?
They are used to enhance precision and control in laser surgeries, particularly in vascular and general surgical procedures.
What specialties typically use this device?
Specialties such as vascular surgery and general surgery commonly use this device for procedures requiring precise laser application.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein and related vascular structures, requiring precise surgical 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.