Premarket Approval (PMA)

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.

• 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
• Predetermined Change Control Plan Authorized: 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