MEL 80 EXCIMER LASER SYSTEM
Trade Name
MEL 80 EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Generic Name
ophthalmic medical laser system(193 nanometer wavelenght)
Applicant
CARL ZEISS, INC.
PMA Number
P060004
Date Received
02/14/2006
Decision Date
08/11/2006
Product Code
LZS
Docket Number
06M-0342
Date Notice
08/25/2006
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for the mel 80 excimer laser system. The device uses an optical zone of 6. 0 to 7. 0 mm in diameter and a transition zone of 1. 7 to 1. 9 mm for total ablation diameter of 7. 7 to 8. 9 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of myopia of less than or equal to -7. 0 d, with or without refractive astigmatism of less than or equal to -3. 0 d, with a maximum mrse of -7. 00 d; 2) in patients who are 21 years of age or older; 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of <=0. 5d.
