TECHNOLAS 217A EXCIMER LASER SYSTEM
Trade Name
TECHNOLAS 217A EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
excimer laser
Applicant
BAUSCH & LOMB SURGICAL, INC.
PMA Number
P990027
Date Received
05/28/1999
Decision Date
02/23/2000
Product Code
LZS
Docket Number
00M-1597
Date Notice
11/03/2000
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the technolas(r) 217a excimer laser system. The devices is indicated to perform laser in-situ keratomileusis (lasik): 1) in treatments for the reduction or eliminatino of myopia (nearsightedness) from -1. 00 to -7. 00 diopters d with less than -3. 00 d astigmatism; 2) in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0. 5 d (in both cylinder and sphere components); and, 3) in patients 21 years of age or older.
