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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameelectrosurgical,radio frequency,refractive correction
Generic Nameelectrosurgical,radio frequency,refractive correction
5 jenner, suite 150
irvine, CA 92618
PMA NumberP010018
Date Received03/14/2001
Decision Date04/11/2002
Product Code
Docket Number 02M-0174
Notice Date 04/25/2002
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009