PMA P970053
- Device
- Nidek EC-5000 Excimer Laser System
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S017
- Product code
- LZS
- Decision date
- 2018-01-12
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Approval for the change of laser head of the excimer laser, software upgrade to accommodate the laser head change, change of the PC and change to the power transformer.
Current openFDA PMA Record#
- Device
- Nidek EC-5000 Excimer Laser System
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S017
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2018-01-12
- Decision code
- APPR
- Date received
- 2017-07-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the change of laser head of the excimer laser, software upgrade to accommodate the laser head change, change of the PC and change to the power transformer.