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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)
Classification Namelaser, ophthalmic
Generic Nameophthalmic medical laser system
Regulation Number886.4390
ApplicantSUNRISE TECHNOLOGIES, INC.
PMA NumberP990078
Supplement NumberS004
Date Received12/26/2000
Decision Date03/16/2001
Product Code
HQF[ Registered Establishments with HQF ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software modification to the eye tracker.
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