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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.
 
DeviceMODEL LI51U & LI61U SOFLEX UV-ABSORBING SILICONE PC IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910061
Supplement NumberS001
Date Received06/10/1997
Decision Date10/21/1997
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Models LI51U and LI61U IOLs.
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