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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 NumberS035
Date Received10/27/2023
Decision Date03/19/2024
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for a change to the wax removal solvent from Exxsol D60 to Exxsol D80 and the process temperature from 58 °C to 72 °C
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