Premarket Approval (PMA)

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.

• 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

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2