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NIDEK Submits 510(k) for Laser to Treat Retinal Diseases and Glaucoma


-New Orleans, LA, USA, November 11, 2001-

NIDEK, Co. Ltd. announced today it has submitted a 510(k) application for the DC-3300 to the U.S. Food and Drug Administration. Once this application is accepted for filing, the FDA will evaluate the DC-3300 for uses in retinal photocoagulation and glaucoma procedures. The DC-3300 is intended to be used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.

NIDEK's DC-3300 is indicated for use in limited and pan-retinal, transpupillary thermotherapy (TTT), endophotocoagulation and transscleral photocoagulation, and glaucoma procedures such as laser trabeculoplasty and iridotomy. Uniquely, the purpose of transscleral treatments is not to improve vision, but to relieve pain.

"Significant eye diseases such as glaucoma and retinal disorders are the leading cause of vision loss and decreased quality of life among seniors," said Hiroshi Okada, vice president and general manager, NIDEK Inc. "With the DC-3300, we hope to protect vision, and help alleviate the pain and discomfort of the more significant vision problems. NIDEK is excited to be in a position to develop and provide new treatment methods for the vision care industry and the patients it treats."

NIDEK is the only manufacturer with a full line of laser coagulators that utilize visible to infrared wavelengths for vision care uses.


The Art of Eye CareNIDEK CO., LTD.

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