| 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 | EC-5000 EXCIMER LASER SYSTEM |
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| Classification Name | excimer laser system |
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| Applicant | NIDEK CO., LTD. |
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| PMA Number | P970053 |
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| Date Received | 11/06/1997 |
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| Decision Date | 12/17/1998 |
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| Product Code | |
| Docket Number | 00M-1640 |
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| Notice Date | 12/08/2000 |
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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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the nidek ec-5000 excimer laser system. This device is indicated for photorefractive keratectomy (prk) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) in prk treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0. 75 diopters (d) to -13. 00d) spherical equivalent (s. E. ) at the spectacle plan, uncomplicated by refractive astigmatism (i. E. , <0. 75d in any meridian). 2) in patients who have a stable history of pretreatment myopia, that is a change of < 0. 50d in sphere or cylinder in the 12 months period preceding treatment for correction of myopia <-7. 0d s. E. , or a change of <1. 00d in sphere or cylinder for correction of myopia >-7. 0d s. E. 3) in patients who are over 21 years of age. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S005 S006 S007
S008 S009 S010 S012 |
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