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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceHYPERION LTK SYSTEM
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Generic Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Applicant
SUNRISE TECHNOLOGIES, INC.
3400 w. warren ave.
fremont, CA 94538
PMA NumberP990078
Date Received11/03/1999
Decision Date06/30/2000
Product Code
LOI
Docket Number 00M-1386
Notice Date 07/11/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S004 S005 
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