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. |
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Device | VIEWPOINT CK SYSTEM |
Generic Name | Electrosurgical, radio frequency, refractive correction |
Applicant | REFRACTEC, INC. 5 JENNER, SUITE 150 IRVINE, CA 92618 |
PMA Number | P010018 |
Supplement Number | S005 |
Date Received | 08/27/2003 |
Decision Date | 03/16/2004 |
Product Code |
MWD |
Docket Number | 04M-0134 |
Notice Date | 03/23/2004 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel 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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