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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 ?
510(k)
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.
FDA-Cleared Indications
- Measurement of corneal curvature during ophthalmic surgical procedures.
Clinical Applications
- Intraoperative measurement of corneal curvature.
- Assessment of corneal shape during procedures requiring precise corneal alignment.
- Use by ophthalmologists in operating rooms or specialized eye-surgery settings.
Practical Considerations
- The instrument should be calibrated and checked before use to support accurate measurements.
- Correct alignment with the patient's eye is necessary for reliable readings.
- It is intended for use with standard ophthalmic surgical equipment and requires trained ophthalmic personnel.
- The device is an optical measuring instrument rather than an implanted device; MRI safety depends on the specific materials and configuration, which should be confirmed in the manufacturer’s labeling.
- The record identifies the device as a Class I instrument cleared through the FDA 510(k) pathway; it does not provide a defined service life or universal replacement interval.
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.