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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 NumberS005
Date Received09/19/2003
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
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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