LASERSCAN LSX EXCIMER LASER SYSTEM
Trade Name
LASERSCAN LSX EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
ophthalmic medical laser system (193 nanometer wavelength)
Applicant
LASERSIGHT TECHNOLOGIES, INC.
PMA Number
P980008
Date Received
03/19/1998
Decision Date
11/12/1999
Product Code
LZS
Docket Number
00M-1231
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the laserscan lsx excimer laser system. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1. 0 to less than -6. 0 diopters (d) with less than or equal to 1. 0 d of astigmatism; in patients with documentation of a stable manifest refraction (+-0. 5d) over the prior one year; and in patients who are 18 years of age or older.
