PMA P970053S012
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S012
- Product code
- LZS
- Decision date
- 2012-12-12
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE LASER DIODE FOR THE AIMING BEAM, THECORRESPONDING MODIFICATION OF THE AIMING BEAM OPTICAL SYSTEM, AND ASSOCIATED LABELING CHANGES.
Current openFDA PMA Record#
- Device
- NIDEK EC-5000 EXCIMER LASER SYSTEM
- Applicant
- Nidek Co., Ltd.
- PMA number
- P970053
- Supplement
- S012
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2012-12-12
- Decision code
- APPR
- Date received
- 2012-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE LASER DIODE FOR THE AIMING BEAM, THECORRESPONDING MODIFICATION OF THE AIMING BEAM OPTICAL SYSTEM, AND ASSOCIATED LABELING CHANGES.