PMA P030008S027
- Device
- WaveLight EX500 Excimer Laser System
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S027
- Product code
- LZS
- Decision date
- 2018-10-26
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Internally source component assembly and testing services for the Model 1125 bed, in addition to externally sourcing this service from the external supplier.
Current openFDA PMA Record#
- Device
- WaveLight EX500 Excimer Laser System
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P030008
- Supplement
- S027
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2018-10-26
- Decision code
- OK30
- Date received
- 2018-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Internally source component assembly and testing services for the Model 1125 bed, in addition to externally sourcing this service from the external supplier.