| 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 | LASERVISION/VISX EXCIMER LASER MODEL C |
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| Classification Name | excimer laser system |
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| Applicant | LASER VISION CENTERS, INC. |
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| PMA Number | P960019 |
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| Date Received | 06/03/1996 |
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| Decision Date | 11/15/1996 |
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Withdrawal Date
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02/26/2002 |
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| Product Code | |
| Docket Number | 97M-0256 |
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| Notice Date | 07/23/1997 |
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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
Device indicated for: 1)ptk in patients w/decreased best corrected visual acuity and/or with disabling pain that are the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The patients must have failed w/alternative treatment options. For safety, the immediate postoperative corneal thickness must not be less than 250 microns. Examples of those conditions that warrant ptk are: a)corneal scars & opacity (from trauma and inactive infections), b)dystrophies (reis-buckler's, granular and lattice), c)thygeson's superficial keratitis, d) irregular corneal surfaces associated w/filamentary keratitis and salzmann's nodular degeneration, e)residual band keratopathy after unsuccessful edta treatment, and, f)scars subsequent to previous (not concurrent) pterygium excision. 2)prk for a 6. 0 ablation zone in patients who are myopic and meet all of the following criteria: 1)1. 0 to 6. 0 diopters (d) of myopia with astigmatism of 2. 0 diopters; b)refractive change is within 0. 5d for one year prior to the laser treatment; and c)18 years of age or older. |
| Supplements: |
S001 S002 |
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