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. |
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Device | STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S057 |
Date Received | 01/02/2019 |
Decision Date | 09/09/2019 |
Product Code |
LZS |
Docket Number | 19M-4238 |
Notice Date | 09/16/2019 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel 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 = 1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and5) with wavefront capture diameter of at least 4 mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
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