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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameBAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP970056
Date Received11/13/1997
Decision Date09/28/1999
Withdrawal Date 04/12/2012
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0309
Notice Date 07/23/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product 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.
Approval Order Approval Order
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