PMA P020050S013
- Device
- WAVELIGHT EX500 EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S013
- Product code
- LZS
- Decision date
- 2013-05-15
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM.
Current openFDA PMA Record#
- Device
- WAVELIGHT EX500 EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S013
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2013-05-15
- Decision code
- APPR
- Date received
- 2013-04-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM.