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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.
 
DeviceVISUMAX FEMTOSECOND LASER
Classification Namefemtosecond laser system for refractive correction
Generic Namefemtosecond laser system for refractive correction
Applicant
Carl Zeiss Meditec, Inc.
5160 hacienda drive
dublin, CA 94568
PMA NumberP150040
Date Received10/30/2015
Decision Date09/13/2016
Product Code
OTL[ Registered Establishments with OTL ]
Docket Number 16M-2735
Notice Date 09/16/2016
Advisory Committee Ophthalmic
Clinical Trials NCT01638390
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the VisuMax Femtosecond Laser. This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >= -1.00 D to <= -8.00 D, with <= -0.50 D cylinder and MRSE <= -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <= 0.50 D MRSE.
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 S003 
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