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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 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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS004
Date Received08/19/1999
Decision Date09/24/1999
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.