| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | MEL 80 EXCIMER LASER SYSTEM |
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| Classification Name | excimer laser system |
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| Generic Name | ophthalmic medical laser system(193 nanometer wavelenght) |
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| Applicant | CARL ZEISS MEDITEC, INC. |
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| PMA Number | P060004 |
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| Date Received | 02/14/2006 |
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| Decision Date | 08/11/2006 |
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| Product Code | |
| Docket Number | 06M-0342 |
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| Notice Date | 08/25/2006 |
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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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the mel 80 excimer laser system. The device uses an optical zone of 6. 0 to 7. 0 mm in diameter and a transition zone of 1. 7 to 1. 9 mm for total ablation diameter of 7. 7 to 8. 9 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of myopia of less than or equal to -7. 0 d, with or without refractive astigmatism of less than or equal to -3. 0 d, with a maximum mrse of -7. 00 d; 2) in patients who are 21 years of age or older; 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of <=0. 5d. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 |
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