| 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 | EC-5000 EXCIMER LASER SYSTEM |
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| Generic Name | Excimer laser system |
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| Applicant | NIDEK CO., LTD.
34-14 MAEHAMA, HIROISHI-CHO
GAMAGORI, AICHI 443-0-0038 |
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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 |
LZS |
| 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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| Recalls | CDRH Recalls |
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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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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 |
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