- Device
- Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S042
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2025-10-01
- Decision code
- OK30
- Date received
- 2025-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a redundant moist heat (steam) sterilizer for routine sterilization of preloaded RayOne devices