Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: WaveLight EX500 Laser System with Patient Bed Swivel 1125
• Generic Name: Excimer laser system
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P020050
• Supplement Number: S030
• Date Received: 05/11/2018
• Decision Date: 08/09/2018
• Product Code: LZS
• Advisory Committee: Ophthalmic
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for change to the firmware of Patient Bed 1125.