NIDEK's AL-Scan Optical Biometer received 510K clearance
- July 22, 2014, Gamagori, JAPAN -
NIDEK, a global leader in the design, manufacturing, and distribution of ophthalmic equipment, announces that the United States Food & Drug Administration (FDA) has issued 510K clearance for its' revolutionary new AL-Scan Optical Biometer that provides 6 essential values for cataract surgery very quickly. The auto tracking and auto shot capabilities make acquisition speedy and straightforward.
The AL-Scan measures 6 fundamental values for cataract surgery in 10 seconds. These values are, axial length, corneal curvature radius, anterior chamber depth, central corneal thickness, white-to-white distance, and pupil size. The rapid measurement enhances clinical efficiency and patient comfort. The AL-Scan incorporates 3-D auto tracking and auto shot, which provides the operator with the most ease, comfort, and accuracy on all measurements.
Nine IOL calculation formulas including Shammas PL for post-LASIK eyes are incorporated in the AL-Scan. Once measurement is completed, the IOL power is automatically calculated using its own measured data. The AL-Scan 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. The AL-Scan represents a fundamental instrument for ophthalmic surgeons.
Mr. Motoki Ozawa, President of NIDEK stated, "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 / post-operative evaluations."
For further information contact:
Public Relations, Planning Dept.
NIDEK CO., LTD.