| 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. |
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| Trade Name | LADARVISION 4000 EXCIMER LASER SYSTEM |
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| Classification Name | excimer laser system |
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| Generic Name | ophthalmic excimer laser system |
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| Applicant | ALCON LABORATORIES,INC |
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| PMA Number | P970043 |
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| Supplement Number | S015 |
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| Date Received | 09/30/2003 |
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| Decision Date | 06/29/2004 |
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| Product Code | |
| Docket Number | 04M-0312 |
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| Notice Date | 07/16/2004 |
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| Advisory Committee |
Ophthalmic |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the ladarvision 4000 excimer laser system. The device uses a 6. 5 mm optical zone, a 9. 00 mm ablation zone, is locked-out for treatments above -9. 75 diopters (d) sphere, -5. 00d cylinder, and -10. 63d spherical equivalent (se), and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of myopic astigmatism up to -8. 00d sphere with -0. 50 to -4. 00d cylinder and up to -8. 00d se at the spectacle plane; 2) in patients who are 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0. 50d for a se of up to -6. 00 d and less than or equal to 0. 75d for a se greater than -6. 00d. |
| Approval Order |
Approval Order
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