BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
Trade Name
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
Classification Name
excimer laser system
Applicant
CHIRON VISION CORP.
PMA Number
P970056
Date Received
11/13/1997
Decision Date
09/28/1999
Product Code
LZS
Docket Number
01M-0309
Date Notice
07/23/2001
Advisory Committee
Ophthalmic
Expedited Review Granted?
No
Information About:
Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement
Approval for 16 units of the keracor(r) 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (prk) in patients who meet the following criteria: 1) in photorefractive keratectomy (prk) treatments for the reduction or elimination of myopia between -1. 50 to -7. 00d of sphere and less than or equal to -4. 5d of astigmatism. 2) in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 50 diopters (in both cylinder an sphere components) for at least one year prior to the date of the pre-operative examination. 3) in patients who are 18 yrs of age or older.
