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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.
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Generic Nameophthalmic medical laser system
PMA NumberP990078
Date Received11/03/1999
Decision Date06/30/2000
Product Code
Docket Number 00M-1386
Notice Date 07/11/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S004 S005