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 EC-5000 EXCIMER LASER |
Generic Name | Excimer laser system |
Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI 443-0-0038 |
PMA Number | P970053 |
Supplement Number | S010 |
Date Received | 08/08/2006 |
Decision Date | 11/08/2006 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM (MODEL CXII) INCLUDING A REDUCTION IN SIZE, THE STANDARDIZATION OF PREVIOUSLY OPTIONAL FEATURES, INCORPORATING THE CONTROL COMPUTER INTO THE COMPUTER (PREVIOUSLY STAND-ALONE) AND REPLACING THE ORIGINAL (MANUAL MAGNIFICATION) MICROSCOPE WITH A NEW MODEL WITH MOTORIZED MAGNIFICATION CONTROL. THE NEW DEVICE WILL BE NAMED THE NIDEK EC-5000 EXCIMER LASER SYSTEM MODEL CXIII. |
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