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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
34-14 maehama, hiroishi-cho
gamagori, aichi 443-0-0038
PMA NumberP970053
Supplement NumberS006
Date Received03/15/2001
Decision Date09/04/2001
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the approved claim for the ec-5000 excimer laser system to allow for threatments using an optical zone size of 5. 5 mm to 6. 5 mm, in addition to the approved optical zone size of t. T mm, for lasik treatment of myopia and myopia with astigmatism. The device, as modified, will continue to be marketed under the trade name nidek ec-5000 excimer laser system and remains indicated for the reduction or elimination of -1. 00 d to -14. 00 d myopia spherical equivalent with or without <=-4 d astigmatism.