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laminar flow phaco tips
Abbott Medical Optics
Summary: Laminar flow phaco tips are specialized surgical instruments used in cataract surgery to emulsify and remove the eye's lens. Ophthalmologists use them in clinical settings to improve surgical precision and outcomes.
FDA Clearance Information
Pathway 510K
Number K111882 ↗
Decision Date November 7, 2011
Product Code HQC
Device Class Class 2
Evidence 0 studies
The laminar flow phaco tips by Abbott Medical Optics received FDA clearance through the 510(k) pathway on November 7, 2011. It is a Class 2 device under product code HQC.
What It Is
Laminar flow phaco tips are designed for use in phacoemulsification, a common technique in cataract surgery. These tips help in the emulsification of the eye's lens by using ultrasonic vibrations. The laminar flow design aims to enhance fluid dynamics during surgery, potentially improving efficiency and reducing thermal damage to surrounding tissues.
Clinical Applications
These tips are primarily used in ophthalmic surgeries, specifically for cataract removal. They are utilized in both outpatient surgical centers and hospital settings. The device is suitable for adult and elderly patients undergoing cataract extraction, a common procedure in the aging population.
Indications for Use
The FDA-cleared indications for laminar flow phaco tips include use in cataract surgery to assist in the removal of the eye's lens. They are intended for patients with cataracts, which cause clouding of the lens and impair vision.
Practical Considerations
Laminar flow phaco tips come in various sizes to accommodate different surgical needs and patient anatomies. They are compatible with standard phacoemulsification systems. Surgeons should be familiar with the specific technique adjustments required for optimal use of laminar flow tips.
Frequently Asked Questions
What is laminar flow phaco tips used for?
They are used in cataract surgery to emulsify and remove the eye's lens.
What specialties typically use this device?
Ophthalmologists typically use this device in cataract surgeries.
What are the FDA-cleared indications?
The device is indicated for use in cataract surgery to assist in lens removal.
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.