| 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 | LADARVISION EXCIMER LASER SYSTEM |
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| Generic Name | Excimer laser system |
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| Applicant | Alcon Laboratories
6201 S. Freeway
Fort Worth,, TX 76134 |
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| PMA Number | P970043 |
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| Date Received | 09/05/1997 |
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| Decision Date | 11/02/1998 |
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| Withdrawal Date | 05/15/2012 |
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| Product Code |
LZS |
| Docket Number | 00M-1592 |
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| Notice Date | 02/05/2001 |
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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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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| 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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