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: VisuMax Femtosecond Laser Accessory– Treatment Pack
• Generic Name: Femtosecond laser system for refractive correction
• Applicant: Carl Zeiss Meditec, Inc.; 5160 Hacienda Dr.; Dublin, CA 94568
• PMA Number: P150040
• Supplement Number: S014
• Date Received: 07/17/2023
• Decision Date: 08/15/2023
• Product Code: OTL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Second clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site.