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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.
 
DeviceSTAR S4 IR Excimer Laser System and iDESIGN Refractive Studio
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS057
Date Received01/02/2019
Decision Date09/09/2019
Product Code LZS 
Docket Number 19M-4238
Notice Date 09/16/2019
Advisory Committee Ophthalmic
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 STAR S4 IR® Excimer Laser System and iDESIGN® Refractive Studio. This device is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients:1) with myopia, with or without astigmatism, as measured by iDESIGN® Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D. 2) with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio System refraction as follows: a) Spherical Equivalent: Magnitude of the difference is less than 0.625 D. b) Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 3) in patients 18 years of age or older.4) with refractive stability (a change of
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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