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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceC-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRayner Intraocular Lenses , Ltd.
1-2 Sackville Trading Estate,
Sackville Rd.
Hove, E. Sussex BN3 7AN
PMA NumberP060011
Supplement NumberS040
Date Received03/18/2025
Decision Date04/09/2025
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
use of the new storage facility for C-flex Intraocular Lens (IOL) (model 570C), C-flex Aspheric IOL (model 970C), 6.0 mm Aspheric IOL (model 600C), RayOne Aspheric IOL (model RAO600C), RayOne Spheric IOL (model RAO100C) and RayOne EMV IOL (model RAO200E)
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