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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 NameVIEWPOINT CK SYSTEM
Classification Nameelectrosurgical,radio frequency,refractive correction
Generic Namerf electrosurgical device
ApplicantREFRACTEC, INC.
PMA NumberP010018
Supplement NumberS009
Date Received01/09/2006
Decision Date04/06/2006
Product Code
MWD
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the labeling with the 24 month clinical study results for ck treatment to improve near vision in the emmetropic and hyperopic presbyopes.
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