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acufex comparative surgical keratometer
Acufex Microsurgical
Summary: The Acufex Comparative Surgical Keratometer is a medical device used to measure the curvature of the cornea during surgical procedures. It is primarily used by ophthalmologists in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K852424 ↗
Decision Date
September 11, 1985
Product Code
HJB
Device Class
Class 1
Evidence
0 studies
The Acufex Comparative Surgical Keratometer was cleared through the FDA 510(k) pathway on September 11, 1985. It is manufactured by Acufex Microsurgical and classified as a Class 1 device.
What It Is
The Acufex Comparative Surgical Keratometer is a precision instrument designed to measure the curvature of the cornea. It is used intraoperatively to ensure accurate corneal measurements, which are crucial for successful surgical outcomes. The device provides real-time data that assists surgeons in making informed decisions during procedures.
Clinical Applications
This device is commonly used in ophthalmic surgeries, particularly in procedures like cataract surgery or corneal transplants where precise corneal measurements are critical. It is typically utilized in hospital operating rooms or specialized eye surgery centers. The primary users are ophthalmologists and surgical teams specializing in eye care.
Indications for Use
The device is indicated for use in measuring corneal curvature, which is essential in surgeries that require precise corneal alignment and adjustments. It is suitable for patients undergoing eye surgeries where corneal measurements can impact the surgical outcome.
Practical Considerations
The keratometer is compatible with standard ophthalmic surgical setups and requires careful calibration before use. It is important to ensure the device is properly aligned with the patient's eye to obtain accurate measurements. Regular maintenance and calibration checks are recommended to maintain precision.
Frequently Asked Questions
What is the Acufex Comparative Surgical Keratometer used for?
It is used to measure the curvature of the cornea during surgical procedures, aiding in accurate surgical outcomes.
What specialties typically use this device?
Ophthalmologists and surgical teams specializing in eye care typically use this device.
What are the FDA-cleared indications?
The device is indicated for measuring corneal curvature during eye surgeries, such as cataract surgery or corneal transplants.
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.