| 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 | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM |
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| Classification Name | excimer laser system |
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| Generic Name | excimer laser system |
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| Applicant | WAVELIGHT AG |
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| PMA Number | P020050 |
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| Supplement Number | S004 |
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| Date Received | 01/30/2006 |
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| Decision Date | 07/26/2006 |
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| Product Code | |
| Docket Number | 06M-0325 |
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| Notice Date | 08/17/2006 |
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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 wavelight allegretto wave excimer laser system used in conjunction with the wavelight allegro analyzer. The device uses a 6. 5 mm optical zone, a 9. 0 mm ablation/treatment zone, and is indicated for wavefront-guided (wfg) laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of up to -7. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -7. 00 d of spherical component and up to 3. 00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as <= 0. 50 d of preoperative spherical equivalent shift over one year prior to surgery. |
| Approval Order |
Approval Order
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