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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.
 
DeviceSOFTEC HD INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
LENSTEC, INC.
1765 commerce ave n
st. petersburg, FL 33716
PMA NumberP090022
Supplement NumberS007
Date Received08/18/2011
Decision Date12/20/2011
Product Code
HQL[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL OF A NEW LENS ANALYZER.
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