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reprocessed phacoemuisification tips
Alliance Medical
Summary: Reprocessed phacoemulsification tips are used in cataract surgery to emulsify and remove the eye's lens. Ophthalmologists utilize these devices in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K050518 ↗
Decision Date
September 23, 2005
Product Code
NKX
Device Class
Class 2
Evidence
0 studies
The reprocessed phacoemulsification tips by Alliance Medical were cleared through the FDA 510k pathway on September 23, 2005. They are classified as Class 2 medical devices.
What It Is
Reprocessed phacoemulsification tips are surgical instruments used in cataract surgery to break up and remove the eye's natural lens. These tips are attached to a phacoemulsification handpiece, which uses ultrasonic vibrations to emulsify the lens, allowing for its removal through a small incision. The reprocessing of these tips involves cleaning, sterilizing, and testing to ensure they meet safety and performance standards.
Clinical Applications
These tips are primarily used in ophthalmology during cataract extraction procedures. They are essential in phacoemulsification, a common technique for cataract removal, allowing for efficient lens emulsification and aspiration. The device is typically used in outpatient surgical centers and hospitals, catering to adult and elderly patients with cataracts.
Indications for Use
The device is indicated for use in patients undergoing cataract surgery, specifically for the emulsification and removal of the eye's lens. It is suitable for individuals diagnosed with cataracts, a condition characterized by clouding of the lens leading to vision impairment.
Practical Considerations
Reprocessed phacoemulsification tips are available in various sizes to accommodate different surgical needs and patient anatomies. They are compatible with standard phacoemulsification machines and require careful handling to maintain sterility and performance. Surgeons should be familiar with the specific technique and settings for optimal use.
Frequently Asked Questions
What is reprocessed phacoemulsification tips used for?
They are used in cataract surgery to emulsify and remove the eye's lens.
What specialties typically use this device?
Ophthalmologists use this device in surgical settings for cataract removal.
What are the FDA-cleared indications?
The device is indicated for emulsifying and removing the lens in cataract surgery.
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.