đź“Š Evidence-Based Reference
contact tips
Cooper Lasersonics
Summary: Contact tips by Cooper Lasersonics are FDA-cleared devices used in various clinical applications. Key evidence highlights their design for minimizing damage to sensitive surfaces.
FDA Clearance Information
Pathway
510K
Number
K861955 ↗
Decision Date
August 14, 1986
Product Code
LNK
Device Class
Class 2
Evidence
0 studies
The contact tips by Cooper Lasersonics were cleared via the FDA 510(k) pathway on August 14, 1986. They are classified as Class 2 devices under product code LNK.
What It Is
Contact tips are designed for minimally invasive contact with sensitive surfaces, such as the preocular area, to minimize irritation and damage. They are used in various clinical applications requiring precision and care.
Clinical Applications
Contact tips are commonly used in procedures involving delicate tissue contact, such as tear fluid collection and laser treatments. They are designed to reduce tissue damage and improve procedural outcomes.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2018, encompassing various study types such as RCTs and case series. These studies explore the design, application, and outcomes of contact tips in clinical settings.
Reported Outcomes
Published studies report that contact tips are effective in minimizing damage to sensitive surfaces, such as the preocular area, during procedures. They are also noted for their role in improving adhesion in bio-inspired systems and reducing energy output in laser applications.
Safety Profile
Reported complications include potential irritation or damage to sensitive tissues if not used properly. However, the design of contact tips aims to mitigate these risks by minimizing contact damage.
Evidence Limitations
The evidence is limited by the diversity of study designs and the specific focus on certain applications. Further research is needed to explore broader clinical applications and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for contact tips?
Contact tips are indicated for use in procedures requiring precise contact with sensitive tissues, such as tear fluid collection and laser treatments.
What outcomes have been reported in clinical studies?
Studies report effective minimization of tissue damage and improved procedural outcomes in applications involving sensitive surfaces.
What complications have been reported?
Reported complications include potential irritation or damage to sensitive tissues, although the design aims to reduce these risks.
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.