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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYPERION LTK SYSTEM
Generic NameLaser, ophthalmic
Regulation Number886.4390
ApplicantSUNRISE TECHNOLOGIES, INC.
3400 W. WARREN AVE.
FREMONT, CA 94538
PMA NumberP990078
Supplement NumberS001
Date Received11/09/2000
Decision Date12/11/2000
Product Code HQF 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE WARNING SECTION OF THE LABELING.
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