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laser delivery systems fiberoptics contact tips
Ximed Medical Systems
Summary: Laser delivery systems fiberoptics contact tips by Ximed Medical Systems are used in various surgical applications. Cleared by FDA via 510k pathway. Key evidence highlights their efficacy in different clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K900463 ↗
Decision Date
March 22, 1990
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The laser delivery systems fiberoptics contact tips were cleared by the FDA through the 510k pathway on March 22, 1990. Manufactured by Ximed Medical Systems, they are classified as Class 2 devices.
What It Is
These devices are fiberoptic contact tips used in laser delivery systems, designed to transmit laser energy for surgical procedures. They are intended for use in various clinical applications requiring precise laser delivery.
Clinical Applications
Commonly used in ophthalmology, oral surgery, and other surgical fields requiring precise laser application. They are particularly useful in procedures like transscleral cyclophotocoagulation and laser osteotomy.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 1998 and 2012. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report that the laser delivery systems fiberoptics contact tips are effective in reducing intraocular pressure in glaucoma treatments and improving surgical precision in oral surgeries. They also demonstrate efficacy in treating vocal fold stenosis and oral mucosal lesions.
Safety Profile
Reported complications include minor thermal injuries and scarring, particularly in delicate tissues. However, the overall safety profile is favorable, with most adverse events being manageable and non-severe.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to compare the efficacy of different fiberoptic diameters.
Frequently Asked Questions
What are the clinical indications for laser delivery systems fiberoptics contact tips?
The device is indicated for use in surgical procedures requiring precise laser delivery, such as glaucoma treatment, oral surgery, and vocal fold stenosis management.
What outcomes have been reported in clinical studies?
Studies have reported effective intraocular pressure reduction in glaucoma, improved surgical precision in oral surgeries, and successful treatment of vocal fold stenosis.
What complications have been reported?
Safety data from evidence indicate minor thermal injuries and scarring as potential complications, though these are generally manageable.
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.