| 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 | VISX EXCIMER LASER SYSTEM MODEL C STAR |
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| Generic Name | Excimer laser system |
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| Applicant | AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035 |
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| PMA Number | P990010 |
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| Date Received | 02/23/1999 |
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| Decision Date | 11/19/1999 |
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| Product Code |
LZS |
| Docket Number | 00M-1447 |
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| Notice Date | 08/18/2000 |
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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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Approval Order Statement
Approval for the VISX Excimer Laser System Model C (STAR S2) which included the right to reference information contained in P930016 from VISX, Inc., of Santa Clara, CA. This device is indicated to perfrom LASIK: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 diopters (D) with or without -0.5 D to -5.0 D of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination. |
| 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 S004 S006 S007 S008 |
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