PMA P970053S016
- Device
- EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S016
- Product code
- LZS
- Decision date
- 2017-06-08
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval for changes to the Final Fit V1.11 and V1.12 Custom Ablation Treatment Planning Software for Nidek EC-5000 Excimer Laser System. The updated Final Fit software is V1.13.
Current openFDA PMA Record#
- Device
- EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S016
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2017-06-08
- Decision code
- APPR
- Date received
- 2017-03-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Final Fit V1.11 and V1.12 Custom Ablation Treatment Planning Software for Nidek EC-5000 Excimer Laser System. The updated Final Fit software is V1.13.