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: NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)
• Generic Name: Excimer laser system
• Applicant: Nidek Co., Ltd.; 34-14 Maehama; Hiroishi-Cho; Gamagori 443-0-0038
• PMA Number: P970053
• Supplement Number: S001
• Date Received: 02/16/1999
• Decision Date: 09/29/1999
• Product Code: LZS
• Docket Number: 00M-1664
• Notice Date: 12/13/2000
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of <0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of <0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age.

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