PMA P060011S025
- Device
- RayOne EMV (Model RAO200E)
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S025
- Product code
- HQL
- Decision date
- 2021-03-26
- Generic name
- Intraocular Lens
- Approval order statement
- Approval for the RayOne EMV, Model RAO200E, which is a preloaded intraocular lens (IOL) injector system extending the RayOne family of one-piece IOLs that incorporate an optical modification.
Current openFDA PMA Record#
- Device
- RayOne EMV (Model RAO200E)
- Applicant
- Rayner Intraocular Lenses , Ltd.
- PMA number
- P060011
- Supplement
- S025
- Decision date
- 2021-03-26
- Decision code
- APPR
- Date received
- 2020-08-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the RayOne EMV, Model RAO200E, which is a preloaded intraocular lens (IOL) injector system extending the RayOne family of one-piece IOLs that incorporate an optical modification.