| 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 | STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM |
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| Classification Name | excimer laser system |
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| Generic Name | excimer laser for ophthalmic use |
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| Applicant | VISX, INCORPORATED |
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| PMA Number | P930016 |
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| Supplement Number | S021 |
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| Date Received | 03/08/2005 |
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| Decision Date | 08/30/2005 |
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| Product Code | |
| Docket Number | 05M-0382 |
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| Notice Date | 09/23/2005 |
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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 star s4 ir excimer laser system with vss and wavescan wavefront system. The device uses a 6. 0 mm optical zone, an 8. 0 mm treatment zone, and is indicated for wavefront-guided (wfg) laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of myopia and myopic astigmatism from -6. 0 to -11. 00 d mrse, with cylinder between 0. 00 and -3. 00 d; 2) in patients 21 years of age or older, and 3) in patients with documented evidence of a change in manifest refraction of no more than 1. 00 d (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. |
| Approval Order |
Approval Order
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