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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, G00C Aspheric lntraocular lenses, RayOne Aspheric RAOG00C, RayOne Spheric RAOl
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 NumberS038
Date Received12/19/2024
Decision Date01/14/2025
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  
a change in the location of microbiology in-process and release testing from a contract testing laboratory to a new internal laboratory
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