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reprocessed phacoemulsification tips
Alliance Medical
Summary: Reprocessed phacoemulsification tips are used in cataract surgery to emulsify and remove the eye's lens. Ophthalmologists utilize these in surgical settings to treat patients with cataracts.
FDA Clearance Information
Pathway 510K
Number K060648 ↗
Decision Date March 19, 2007
Product Code NKX
Device Class Class 2
Evidence 0 studies
The reprocessed phacoemulsification tips by Alliance Medical were cleared via the FDA 510k pathway on March 19, 2007. They are classified as Class 2 devices under product code NKX.
What It Is
Reprocessed phacoemulsification tips are surgical instruments used in cataract surgery. They function by delivering ultrasonic energy to emulsify the eye's lens, allowing for its removal. These tips are reprocessed, meaning they have been cleaned, sterilized, and tested for reuse, providing a cost-effective option for surgical centers.
Clinical Applications
These tips are primarily used in ophthalmic surgeries, specifically cataract extraction procedures. They are employed in both hospital and outpatient surgical settings. The primary patient population includes individuals with cataracts, often older adults, who require lens removal and replacement.
Indications for Use
The FDA indications suggest that these tips are intended for use in cataract surgeries to emulsify and remove the lens. This is typically indicated for patients with significant lens opacities affecting vision.
Practical Considerations
Reprocessed phacoemulsification tips are available in various sizes to accommodate different surgical needs. They are compatible with standard phacoemulsification machines. Surgeons should ensure proper technique and compatibility with their equipment to optimize outcomes.
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 in surgical settings use this device.
What are the FDA-cleared indications?
They are indicated for use in cataract surgeries 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.