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: VISX EXCIMER LASER SYSTEM MODELS B AND C
• Generic Name: Excimer laser system
• Applicant: AMO Manufacturing USA, LLC; 510 Cottonwood Drive; Milpitas, CA 95035
• PMA Number: P930016
• Supplement Number: S005
• Date Received: 07/23/1997
• Decision Date: 01/29/1998
• Product Code: LZS
• Docket Number: 99M-0293
• Notice Date: 07/15/1999
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No

Approval Order Statement  
Approval for the VISX Excimer Laser System (Models B and C). This device is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0 mm major axis. The PRK procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0 D spherical equivelent at the corneal plane with less than or equal to -1.0 D of astigmatism; or 3) in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0 D spherical myopia at the spectacle plane and up to -4.0 D of astigmatism.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling