Ultrasonic Biometry Instrument Receives FDA Clearance

-Fremont, CA USA, May 31, 2002-

NIDEK Inc. announced today that the Food and Drug Administration has granted 510 (k) clearance for the company's US-1800 Echoscan ultrasonic biometry instrument for measuring axial length, corneal thickness and other internal dimensions of the eye. Accurate intraocular measurements are critical to the success of certain surgical procedures, such as refractive and cataract surgery.

The US-1800 Echoscan utilizes ultrasonography to very precisely and quickly measure the axial length of the eye and relative position of internal ocular structures. These measurements are used to calculate the correct intraocular lens (IOL) implant power required to restore vision after cataract extraction. The US-1800 can also measure corneal thickness---an important consideration in laser refractive surgery. Other features of the instrument include a pre-programmed selection of advanced IOL power calculation formulas and a large, easy-to-use color touch-screen display.

"The approval of NIDEK's US-1800 Echoscan allows us to provide the ophthalmologist with yet another versatile tool for improving the outcomes of laser refractive surgery and cataract surgery" stated Hiroshi Okada, vice president and general manager, NIDEK. Inc. "We are very pleased to make this advanced technology available to U.S. eye surgeons."

NIDEK offers a complete line of surgical and diagnostic instrumentation for vision care providers.


For further information contact:
Contact:
Public Relations, Planning Dept.
NIDEK Co., Ltd.
Email: info@nidek.co.jp