Amer. Medical Optics Digital Kerato-

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K842504 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• What clinical conditions or procedures is this keratometer primarily used to evaluate or assist with?

  This Digital Keratometer is designed to measure corneal curvature and provide refractive power data in diopters, which aids in diagnosing and managing refractive errors, keratoconus, and preoperative planning for cataract or refractive surgeries. It helps clinicians assess corneal topography to inform treatment decisions.

• Is this device single-use or reusable, and what cleaning or maintenance considerations should be noted?

  The Digital Keratometer is supplied as a reusable instrument, meaning it is intended for repeated use in clinical settings. While the data does not specify sterility requirements, proper cleaning and maintenance are essential to ensure accuracy and prevent cross-contamination between patients. Follow manufacturer guidelines for disinfection and upkeep.

• How is this device regulated, and what does its FDA clearance status indicate?

  This device holds an FDA 510(k) clearance (K842504) under the classification of Class III ophthalmic instruments. The clearance indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in clinical ophthalmology.

• Are there any special storage requirements for this keratometer?

  The provided data does not mention specific storage conditions such as temperature, humidity, or environmental protection. However, standard clinical practices for ophthalmic instruments should be followed to maintain accuracy and functionality, such as keeping it in a clean, dry environment when not in use.