VISX EXCIMER LASER SYSTEM MODEL C "STAR"
Trade Name
VISX EXCIMER LASER SYSTEM MODEL C "STAR"
Classification Name
excimer laser system
Applicant
AMO MANUFACTURING USA, LLC
PMA Number
P990010
Date Received
02/23/1999
Decision Date
11/19/1999
Product Code
LZS
Docket Number
00M-1447
Date Notice
08/18/2000
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the visx excimer laser system model c (star s2) which included the right to reference information contained in p930016 from visx, inc. , of santa clara, ca. This device is indicated to perfrom lasik: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14. 0 diopters (d) with or without -0. 5 d to -5. 0 d of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0. 5 d (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.
