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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.
Classification Nameelectrosurgical,radio frequency,refractive correction
Generic Nameelectrosurgical,radio frequency,refractive correction
5 jenner, suite 150
irvine, CA 92618
PMA NumberP010018
Supplement NumberS004
Date Received07/16/2003
Decision Date07/31/2003
Product Code
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility for the sub-assembly of the rcs-300 console. The manufacturing facility is located at refractec, inc. , irvine, california.