NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053/S011 · decided 2013-09-30
Approval details
- PMA number
- P970053
- Supplement
- S011
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2007-03-30
- Decision date
- 2013-09-30
- Days to decision
- 2376 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- 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 OV
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