PMA (pre-market approval) supplement expands Nidek's PKRr (photorefractive keratectomy) therapy:
This article was originally published in Clinica
Nidek has received a premarket approval supplement from the US FDA to expand the use of its photorefractive keratectomy laser system to treat patients who have moderate myopia with astigmatism. The EC-5000 system, which is already approved for reducing or eliminating myopia ranging in severity from 0.75 to 13.00 dioptres, can now be used to treat myopia ranging from 1.00 to 8.00 dioptres with refractive astigmatism ranging between 0.50 and 4.00 dioptres cylinder by manifest refraction. The Japanese company, which has US operations in Fremont, California, also received FDA clearance for its MK-2000 keratome system for use during lamellar procedures.
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