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laminar flow phaco tips and irrigation sleeve 21g reusable
Abbott Medical Optics
Summary: The laminar flow phaco tips and irrigation sleeve are used in cataract surgery to emulsify and remove the lens. Ophthalmologists use this device in surgical settings.
FDA Clearance Information
Pathway 510K
Number K121721 ↗
Decision Date October 15, 2012
Product Code HQC
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on October 15, 2012. Manufactured by Abbott Medical Optics, it is classified as a Class 2 device under product code HQC.
What It Is
The laminar flow phaco tips and irrigation sleeve are surgical instruments used in phacoemulsification, a common technique for cataract removal. The device facilitates the emulsification of the eye's lens using ultrasonic energy, allowing for its removal through a small incision. The laminar flow design helps optimize fluid dynamics during surgery, enhancing safety and efficiency.
Clinical Applications
This device is primarily used in ophthalmology, particularly in cataract surgery. It is employed in both outpatient and inpatient surgical settings. The device is suitable for adult and elderly patients who require cataract removal, a common procedure to restore vision impaired by lens opacification.
Indications for Use
The device is indicated for use in patients requiring cataract surgery, specifically for the emulsification and removal of the natural lens. It is designed to improve surgical outcomes by providing efficient lens removal.
Practical Considerations
The device is reusable and typically comes in a 21-gauge size, compatible with standard phacoemulsification systems. Surgeons should ensure compatibility with their surgical equipment and be familiar with the laminar flow technique to optimize performance.
Frequently Asked Questions
What is laminar flow phaco tips used for?
It is used for emulsifying and removing the lens during cataract surgery.
What specialties typically use this device?
Ophthalmologists specializing in cataract surgery use this device.
What are the FDA-cleared indications?
The device is indicated for use in cataract surgery to emulsify and remove the lens.
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.