đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use during cataract extraction procedures to emulsify and remove the natural lens.
- Intended for use with compatible phacoemulsification systems during ophthalmic surgery.
Clinical Applications
- Ultrasonic emulsification of the natural lens during cataract surgery.
- Removal of lens fragments during cataract extraction.
- Use in hospital operating rooms and outpatient ophthalmic surgery centers when used with compatible phacoemulsification equipment.
Practical Considerations
- The tip must be compatible with the specific phacoemulsification handpiece and console being used.
- Different tip sizes and designs may be selected according to the surgeon’s technique, incision size and lens characteristics.
- Because the tips are reprocessed, they must undergo validated cleaning, sterilization and functional testing before reuse according to the facility’s policies and the device labeling.
- Inspect the tip and handpiece before use for damage, blockage, deformation or impaired function.
- The tip is not an MRI device; it should be removed from the operative field and handled according to institutional MRI safety procedures if MRI is required.
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.