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Nidek EC-5000 receives approval
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FREMONT, Calif. — Nidek Inc.’s EC-5000 excimer laser system received approval from the Food and Drug Administration for the treatment of laser in situ keratomileusis.
This approval allows treatment for the reduction or elimination of myopia with or without astigmatism ranging from 1 to 14 D, in terms of manifest refraction spherical equivalent with refractive astigmatism of less than or equal to 4 D of cylinder by manifest refraction.
Nidek’s EC-5000 excimer laser system was previously approved for the reduction and elimination of myopia in the low, moderate and high ranges from 0.75 D to 13 D. The laser system is also approved for moderate myopia with astigmatism ranging in severity from 1 D to 8 D, with refractive astigmatism from 0.5 D to 4 D cylinder by manifest refraction, using photorefractive keratectomy.