Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceHYPERION LTK SYSTEM
Generic NameLaser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
ApplicantSUNRISE 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 ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S004 S005 
-
-