Myopia News Briefs

New OCULUS Pentacam AXL Wave Receives FDA 501(k) Clearance

March 9, 2021

The Food and Drug Administration (FDA) has given 501(k) clearance to the new OCULUS Pentacam AXL Wave. This gives OCULUS the green light to begin commercial distribution of the newest Pentacam.

The Pentacam AXL Wave is the latest and most versatile member of the Pentacam family, incorporating intuitive reports based on clinical studies, with guaranteed network compatibility and full operability of all Pentacam software and examinations.

The established functions of anterior segment tomography and optical biometry have been complemented by retroillumination and a Hartman-Shack sensor for total eye wavefront and objective refraction. A new examination routine guides the user through the imaging process. The measuring process is straightforward, user-independent, fast, and patient-friendly.

The intuitive guide allows both eyes to be examined in less than five minutes. These new hardware and software features allow optical performance analysis of the total cornea, total eye and crystalline lens or implanted IOL. In addition, the new Pentacam AXL Wave comes with a comprehensive, clearly arranged overview display showing all parameters for corneal screening, IOL power selection, IOL power calculation, ICL selection and calculation and pupil diameter under dimmed and dark conditions. The standard software package with the IOL calculator and its built-in IOL database provide verification of findings in numerous clinical applications such as corneal refractive surgery, lens refractive surgery, presbyopia solutions and standard cataract surgery.

 

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