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 2000 EC-5000 EXCIMER LASER SYSTEM |
Generic Name | excimer laser system |
Applicant |
NIDEK CO., LTD. |
34-14 maehama, hiroishi-cho |
gamagori, aichi 443-0-0038 |
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PMA Number | P970053 |
Supplement Number | S011 |
Date Received | 03/30/2007 |
Decision Date | 09/30/2013 |
Product Code |
LZS
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Docket Number | 13M-1362 |
Notice Date | 10/30/2013 |
Advisory Committee |
Ophthalmic |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product |
No
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Approval Order Statement
APPROVAL FOR THE NIDEK EC-5000 EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR TOPOGRAPHY-ASSISTED LASER- ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENT USING THE FINAL FIT¿ CUSTOM ABLATION TREATMENT PLANNING SOFTWARE FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS FROM -1.0 TO -4.0 D OF SPHERE WITH ASTIGMATIC REFRACTIVE ERRORS FROM >-0.5 TO -2.0 D AT THE SPECTACLE PLANE; IN PATIENTS 21 YEARS OF AGE OR OLDER; AND, IN PATIENTS WITH DOCUMENTED STABILITY OF MANIFEST REFRACTION OVER THE PRIOR YEAR, DEMONSTRATED BY A CHANGE IN MRSE NOT GREATER THAN ±0.5 D. |
Approval Order |
Approval Order
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Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
Labeling Part 2
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