Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | HYPERION LTK SYSTEM |
Generic Name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
Applicant | SUNRISE TECHNOLOGIES, INC. 3400 W. WARREN AVE. FREMONT, CA 94538 |
PMA Number | P990078 |
Date Received | 11/03/1999 |
Decision Date | 06/30/2000 |
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
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Supplements: |
S001 S004 S005 |
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