Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | NIDEK EXCIMER LASER SYSTEM EC-5000 |
Generic Name | Excimer laser system |
Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI 443-0-0038 |
PMA Number | P970053 |
Supplement Number | S014 |
Date Received | 08/18/2014 |
Decision Date | 11/14/2014 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW 200 HZ EYETRACKER, WHICH REPLACES THE EXISTING 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE IR ILLUMINATION. |
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