NIDEK EXCIMER LASER SYSTEM EC-5000
FDA premarket approval P970053/S014 · decided 2014-11-14
Approval details
- PMA number
- P970053
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIDEK EXCIMER LASER SYSTEM EC-5000
- Generic name
- Excimer laser system
- Applicant
- Nidek Co., Ltd.
- Date received
- 2014-08-18
- Decision date
- 2014-11-14
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Gamagori
- Statement
- APPROVAL FOR A NEW 200 HZ EYETRACKER, WHICH REPLACES THE EXISTING 200 HZ EYETRACKER USED WITH THE EC-5000 EXCIMER LASER. THIS CHANGE ALSO INCLUDES MODIFICATION TO THE ASSOCIATED CAMERA AND SOFTWARE AS WELL AS THE IR ILLUMINATION.
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