| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | KONTUR 55 EW |
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| Generic Name | Lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | KONTUR KONTACT LENS CO., INC.
642 ALFRED NOBEL DR.
HERCULES, CA 94547 |
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| PMA Number | P850078 |
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| Date Received | 10/30/1985 |
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| Decision Date | 01/31/1986 |
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Withdrawal Date
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04/27/2015 |
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| Product Code |
LPM |
| Docket Number | 86M-0109 |
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| Notice Date | 03/28/1986 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE SPHERICAL AND TORIC CONFIGURATIONS OF THE KONTUR SOFTMETHAFILCON A HY4ROPHILIC CONTACT LENS THE SPHERICAL LENS IS INDICATED FORDAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT APHAKICPERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROP1C THE LENS MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1 50 DIOPTERS D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY THE LENS RANGES 1N POWERS FROM 20 00 D TO 20 00 D THE TORIC LENS IS INDICATED FOR DAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY 1N NOT APHAKIC PERSONS W1TH NOND1SEASED EYES THAT ARE MYOPIC HYPEROPIC OR HAVE REFRACTIVE ASTIGMATISM NOT EXCEEDING 5 00 D THAT DOES NOT 1NTERFERE WITH VISUAL ACUITY THE LENS CANGES IN POWERS FROM 20 00 D TO 10 00 D BOTH CONFIGURATIONS OF THE LENS ARE TO BE DISINFECTED USING A CHEMICAL LENS CARE SYSTEM. |
| Supplements: |
S001 S002 S003 S004 S006 S007 S008 S010 S012 S013 |
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