PMA P970053S008
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S008
- Product code
- LZS
- Decision date
- 2004-05-28
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL TO REPLACE THE 60HZ EYETRACKER WITH THE 200 HZ EYETRACKER IN THE NIDEK EC-5000 EXCIMER LASER SYSTEM FOR THE TREATMENT OF MYOPIA AND MYOPIC ASTIGMATISM.
Current openFDA PMA Record#
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S008
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2004-05-28
- Decision code
- APPR
- Date received
- 2004-04-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REPLACE THE 60HZ EYETRACKER WITH THE 200 HZ EYETRACKER IN THE NIDEK EC-5000 EXCIMER LASER SYSTEM FOR THE TREATMENT OF MYOPIA AND MYOPIC ASTIGMATISM.