PMA P030008S033
- Device
- WaveLlght EX500 Laser System
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S033
- Product code
- LZS
- Decision date
- 2021-02-18
- Generic name
- Excimer laser system
- Approval order statement
- Approval for labeling changes to add and strengthen contraindications.
Current openFDA PMA Record#
- Device
- WaveLlght EX500 Laser System
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S033
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2021-02-18
- Decision code
- APPR
- Date received
- 2021-01-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to add and strengthen contraindications.