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Nidek receives FDA approval for hyperopia treatment with its excimer laser

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FREMONT, Calif. — Nidek Inc. has received Food and Drug Administration approval for its EC-5000 excimer laser for performing hyperopic LASIK procedures, the company announced.

The FDA approved the device to treat hyperopia and hyperopic astigmatism of 0.5 D to 5 D sphere and up to 2 D cylinder, according to a press release from Nidek.

The approval was based on a study of 291 eyes. At 6 months' follow-up, 60% of eyes had achieved uncorrected visual acuity of 20/20 or better and 99% achieved 20/40 or better, according to the release.