WALTHAM, Mass., Nov. 3 -- Summit Technology Inc. reported that the Pre-market Application (PMA) Supplement filed by its subsidiary, Autonomous Technologies, for LASIK treatment of myopia and hyperopia with or without astigmatism has been accepted for filing by the US FDA. The PMA Supplement seeks approval for the use of the Autonomous LADARVision System in LASIK procedures to correct farsightedness up to +6 diopters sphere and up to -6 D of astigmatism, in addition to nearsightedness up to -11 D sphere and up to -6 D of astigmatism, with or without astigmatism. FDA filing of the PMA Supplement is the first step in the approval process.
Summit Technology said the FDA has indicated that its panel on ophthalmic devices will review the PMA in the near future. The Autonomous LADARVision System is presently approved for PRK treatment of myopia up to -10 D sphere and up to -4 D of astigmatism.