DevicePMAs@therightstef:P990078_S000 JSONTXT

Approval for the sunrise hyperion(tm) ltk system. The device is indicated for temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction sphericla equivalent (mrse) at the spectacle plane (with cylinder less than or equal to +-0.75 diopters) who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0.50d in spherical, and cylindrical components of the manifest refracs