Nidek’s optical biometer gains 510(k) clearance

Fremont, CA-The FDA has issued 510(k) clearance to Nidek’s AL-Scan optical biometer.

The device provides six essential values for cataract surgery very quickly, and the auto tracking and auto shot capabilities make acquisition speedy and straightforward, said the company in a prepared statement.

The essential values are:

• Axial length

• Corneal curvature radius

• Anterior chamber depth

• Central corneal thickness

• White-to-white distance

• Pupil size

“The rapid measurement enhances clinical efficiency and patient comfort,” Nidek said, and also incorporates three-dimensional auto tracking and auto shot.

Nine IOL calculation formulas-including Shammas PL for post-LASIK eyes-are incorporated in the device as well. Once measurement is completed, the IOL power is automatically calculated using its own measured data. The device can optimize the IOL constants by statistically calculating with the postoperative refractive power.

For toric IOL implants, a digital protractor is included to determine the angle between the steepest corneal meridian and the line passing through a landmark such a prominent vessel. The image of the eye with an overlay of the digital protractor can be used in the operating room for accurate alignment of toric IOLs.

“We are pleased to have this clearance, and confident the results reflect the quality of our diagnostic tools in measurements that assist doctors in pre/postoperative evaluations,” said Motoki Ozawa, president of Nidek.

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