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Device | BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS GMBH PERFECT VISION PO BOX 17190 ANAHEIM HILLS, CA 92817 |
PMA Number | P970056 |
Date Received | 11/13/1997 |
Decision Date | 09/28/1999 |
Withdrawal Date
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04/12/2012 |
Product Code |
LZS |
Docket Number | 01M-0309 |
Notice Date | 07/23/2001 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
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