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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.
 
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
Supplement NumberS003
Date Received03/23/2018
Decision Date10/04/2018
Product Code
OTL[ Registered Establishments with OTL ]
Docket Number 18M-3842
Notice Date 10/25/2018
Advisory Committee Ophthalmic
Clinical Trials NCT02430428
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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 with or without astigmatism:1) For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters;2) For cylinder from -0.75 diopters through -3.00 diopters; and3) When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D in magnitude.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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