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: Rayner C-flex 570, C-flex Aspheric 970, 600 Aspheric Intraocular lenses, RayOne Aspheric RA0600, RayOne Spheric RAO100 a
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Rayner Intraocular Lenses , Ltd.; 1-2 Sackville Trading Estate,; Sackville Rd.; Hove, E. Sussex BN3 7AN
• PMA Number: P060011
• Supplement Number: S034
• Date Received: 08/10/2023
• Decision Date: 09/05/2023
• Product Code: HQL
• 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  
Add an alternate supplier of molded parts.