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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
PMA NumberP080004
Supplement NumberS015
Date Received03/19/2014
Decision Date06/16/2014
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an optical design curvature modification to the isert® model 251 to add a controlled positive spherical aberration to the optic. The device, as modified, will be marketed under the trade name isert® gemetric model 751 and is indicated for implantation after extracapsular cataract extraction or phacoemulsification of cataracts in adults. This lens is intended for placement in the capsular bag.
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