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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceKAMRA INLAY
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ACUFOCUS, INC.
32 discovery
suite 200
irvine, CA 92618
PMA NumberP120023
Date Received12/12/2012
Decision Date04/17/2015
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 15M-1326
Notice Date 04/29/2015
Advisory Committee Ophthalmic
Clinical Trials NCT00819299
NCT00850031
NCT01352442
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE KAMRA INLAY. THE KAMRA INLAY IS INDICATED FOR INTRASTROMAL CORNEAL IMPLANTATION TO IMPROVE NEAR VISION BY EXTENDING THE DEPTH OF FOCUS IN THE NON-DOMINANT EYE OF PHAKIC, PRESBYOPIC PATIENTS BETWEEN THE AGES OF 45 AND 60 YEARS OLD WHO HAVE CYCLOPLEGIC REFRACTIVE SPHERICAL EQUIVALENT OF +0.50 D TO -0.75 D WITH LESS THAN OR EQUAL TO 0.75 D OF REFRACTIVECYLINDER, WHO DO NOT REQUIRE GLASSES OR CONTACT LENSES FOR CLEAR DISTANCE VISION, AND WHO REQUIRE NEAR CORRECTION OF +1.00 D TO +2.50 D OF READING ADD.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 
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