问题描述:
求翻译.英文看不懂.
The Nidek EC-5000 Excimer Laser System was originally approved on December 17,
1998 under PMA P970053 for the limited indication for myopic photorefractive
keratectomy (PRK) uncomplicated by astigmatism (< -0.75 D) in patients 21 years of age
or older with -0.25 to -13.0 D of myopia whose refractive change for one year prior to
treatment is within =0.25 D for low myopia (5 -7.0 D MRSE) or within ± 0.25D for high
myopia (> -7.0 D MRSE).
The clinical indication was expanded in Supplement 1to
include PRK treatment of myopic astigmatism (-1.00 to -8.00 D MRSE with -0.5 Io -4.00
D cylinder). Supplement 6 (approved September 4, 2001) flirther expanded the clinical
indication to include laser assisted in-situ keratomilicusis (LASIK) for the treatment of
myopic astigmatism (-0.25 to -14.00 D MRSE with up to -6.00 D astigmatism) using an
optical zone between 5.0 and 6.5 mm in patients 21 years of age or older. Supplements 7
and 8 added the use of active eye trackers operating at 60 Hz and 200 Hz, respectively,
for the approved myopic and myopic astigmatism indications.
NIDEK是个品牌 PRK是手术方法不用翻译
The Nidek EC-5000 Excimer Laser System was originally approved on December 17,
1998 under PMA P970053 for the limited indication for myopic photorefractive
keratectomy (PRK) uncomplicated by astigmatism (< -0.75 D) in patients 21 years of age
or older with -0.25 to -13.0 D of myopia whose refractive change for one year prior to
treatment is within =0.25 D for low myopia (5 -7.0 D MRSE) or within ± 0.25D for high
myopia (> -7.0 D MRSE).
The clinical indication was expanded in Supplement 1to
include PRK treatment of myopic astigmatism (-1.00 to -8.00 D MRSE with -0.5 Io -4.00
D cylinder). Supplement 6 (approved September 4, 2001) flirther expanded the clinical
indication to include laser assisted in-situ keratomilicusis (LASIK) for the treatment of
myopic astigmatism (-0.25 to -14.00 D MRSE with up to -6.00 D astigmatism) using an
optical zone between 5.0 and 6.5 mm in patients 21 years of age or older. Supplements 7
and 8 added the use of active eye trackers operating at 60 Hz and 200 Hz, respectively,
for the approved myopic and myopic astigmatism indications.
NIDEK是个品牌 PRK是手术方法不用翻译
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