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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.
 
DeviceVIEWPOINT CK SYSTEM
Classification Nameelectrosurgical,radio frequency,refractive correction
Generic Nameelectrosurgical,radio frequency,refractive correction
Applicant
REFRACTEC, INC.
5 jenner, suite 150
irvine, CA 92618
PMA NumberP010018
Supplement NumberS005
Date Received08/27/2003
Decision Date03/16/2004
Product Code
MWD
Docket Number 04M-0134
Notice Date 03/23/2004
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE VIEWPOINT CK SYSTEM. THE DEVICE IS INDICATED FOR THE TEMPORARY INDUCTION OF MYOPIA (-1.00 D TO -2.00 D) TO IMPROVE NEAR VISION IN THE NON-DOMINANT EYE OF PRESBYOPIC HYPEROPES OR PRESBYOPIC EMMETROPES, VIA SPHERICAL HYPEROPIC TREATMENT OF 1.00 TO 2.25 D, IN PATIENTS: 1) 40 YEARS OF AGE OF GREATER; 2) WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF <0.50 D IN SPHERICAL AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION; 3) WITH <=0.75 D OF CYCLOPLEGIC REFRACTIVE CYLINDER; AND 4) WITH A SUCCESSFUL PREOPERATIVE TRIAL OF MONOVISION OR HISTORY OF MONOVISION WEAR (I.E., DOMINANT EYE CORRECTED FOR DISTANCE VISION AND NON-DOMINANT EYE CORRECTED FOR NEAR VISION).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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