Sunrise Places 138 Lasers in First Year
FREMONT, Calif., July 10 -- Sunrise Technologies International Inc. has reported 138 shipments of Hyperion LTK Systems since the device was granted market approval by the US Food and Drug Administration last June. The company shipped 28 laser systems in the second quarter of this year, including 5 to ophthalmic centers in South Korea.
The FDA approved the system for the temporary reduction of hyperopia in patients with +0.75 TO +2.50 diopters of MRSE with less than or equal to +/- 0.75 diopters of astigmatism, who are 40 years of age or older with documented stability of refraction for the prior six months, as demonstrated by a change of less than or equal to 0.50 D in spherical and cylindrical components of the manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their refractive correction.
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