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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.
 
DeviceRayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1
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 NumberS033
Date Received02/09/2023
Decision Date02/27/2023
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  
Update the software used with the optical test instruments to evaluate the depth of focus of the proposed EMV IOLs.
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