PMA P970053S005
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S005
- Product code
- LZS
- Decision date
- 2001-03-15
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL TO MODIFY THE DEVICE BY THE ADDITION OF SECURITY SOFTWARE AND A HARDWARE BLOCK TO PRECLUDE THE USE OF UNAPPROVED SOFTWARE.
Current openFDA PMA Record#
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S005
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2001-03-15
- Decision code
- APPR
- Date received
- 2001-01-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO MODIFY THE DEVICE BY THE ADDITION OF SECURITY SOFTWARE AND A HARDWARE BLOCK TO PRECLUDE THE USE OF UNAPPROVED SOFTWARE.