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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.
 
DeviceiDESIGNRefractive Studio, STAR Excimer Laser System
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS053
Date Received09/29/2017
Decision Date06/15/2018
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to upgrade the software and hardware to its combined corneal topographer and wavefront aberrometry device, the iDesign Advanced WaveScan Studio System, and expansion of the indications for use of the iDesign system, in combination with the STAR S4 IR Excimer Laser Systems, to include the monovision treatment of myopic presbyopes. The device, as modified, will be marketed under the trade name iDesign Refractive Studio, STAR Excimer Laser System and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision,;2) with myopic astigmatism up to -6.00 D spherical equivalent as measured by iDESIGN® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio 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. c. Cylinder Axis: If either the manifest cylinder entered into the iDESIGN® Refractive Studio or the iDESIGN® Refractive Studio cylinder selected for treatment is less than 0.5 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance is linearly reduced from 15>= (0.5 D) to 7.5 >= (7.0 D or greater) based on the average magnitude of both cylinders;4) with documented evidence of a change in manifest refraction of no more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 5) with a successful preoperative trial of monovision or history of monovision experience.
Post-Approval StudyShow Report Schedule and Study Progress
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