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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.
Generic NameFemtosecond laser system for refractive correction
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
PMA NumberP150040
Date Received10/30/2015
Decision Date09/13/2016
Product Code OTL 
Docket Number 16M-2735
Notice Date 09/16/2016
Advisory Committee Ophthalmic
Clinical TrialsNCT01638390
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014