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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 |
PMA Number | P970053 |
Supplement Number | S011 |
Date Received | 03/30/2007 |
Decision Date | 09/30/2013 |
Product Code |
LZS |
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 |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |