NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA premarket approval P970053/S007 · decided 2002-10-28
Approval details
- PMA number
- P970053
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2002-05-23
- Decision date
- 2002-10-28
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- APPROVAL FOR THE ADDITION OF A WINDOWS OPERATING SYSTEM AND EYE TRACKING SYSTEM TO THE NIDEK EC-5000 EXCIMER LASER SYSTEM.
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