| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | VIEWPOINT(TM) CK SYSTEM |
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| Generic Name | Electrosurgical, radio frequency, refractive correction |
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| Applicant | REFRACTEC, INC.
5 JENNER, SUITE 150
IRVINE, CA 92618 |
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| PMA Number | P010018 |
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| Date Received | 03/14/2001 |
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| Decision Date | 04/11/2002 |
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| Product Code |
MWD |
| Docket Number | 02M-0174 |
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| Notice Date | 04/25/2002 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE REFRACTEC VIEWPOINT CK SYSTEM. THIS DEVICE IS INDICATED FOR: TEMPORARY REDUCTION OF SPHERICAL HYPEROPIA IN PATIENTS WHO HAVE 0.75 D TO 3.25 D OF CYCLOPLEGIC SPHERICAL HYPEROPIA, LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVE ASTIGMATISM (MINUS CYLINDER FORMAT), A CYCLOPLEGIC SPHERICAL EQUIVALENT OF 0.75 D TO 3.00 D, AND ARE 40 YEARS OF AGE OR GREATER WITH A DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTH, AS DEMONSTRATED BY A CHANGE OF LESS THAN 0.50 D IN SPHERICAL AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACTION. THE MAGNITUDE OF CORRECTION WITH THIS TREATMENT DIMINISHES OVER TIME, WITH SOME PATIENTS RETAINING SOME OR ALL OF THEIR INTENDED REFRACTIVE CORRECTION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 |
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