This article was originally published in The Gray Sheet
Firm's LADARVision system premarket approval application supplement seeking expanded labeling for laser in situ keratomileusis (LASIK) vision correction of hyperopia with or without astigmatism up to -6 diopters hyperopia and -6 D astigmatism will be reviewed March 17 by FDA's Ophthalmic Advisory Panel, Summit announces Feb. 10. Request for labeling to include LASIK indication for nearsightedness (up to -11 diopters, up to 6 D astigmatism) is still pending at FDA. Designed and developed by Summit's Autonomous Technologies unit, the device currently is approved for photorefractive keratectomy treatment of myopia up to -10 D and up to -4 D astigmatism
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