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Device | LADARVISION EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Date Received | 09/05/1997 |
Decision Date | 11/02/1998 |
Withdrawal Date
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05/15/2012 |
Product Code |
LZS |
Docket Number | 00M-1592 |
Notice Date | 02/05/2001 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Indicated for use in photorefractive keratectomy (PRK) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1.00D to -10.00D of sphere and less than or equal to -4.00D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50D and -10.00D spherical equivalent (SE) at the spectacle plane where sphere or cylinder is at least 1.00D; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50D for corrections up to -7.00D SE, and less than or equal to -1.00D for corrections greater than -7.00 D SE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 S014 S015 S016 S017 S019 S020 S021 S022 S023 S025 S026
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