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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS)
Generic NameLenses, soft contact, extended wear
ApplicantCOOPERVISION, INC.
370 WOODCLIFF DRIVE
SUITE 200
FAIRPORT, NY 14450-0000
PMA NumberP850079
Supplement NumberS040
Date Received05/15/2002
Decision Date06/13/2002
Product Codes LPM MVN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXTENDED WEAR APPROVAL FOR THE FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES WITH UV ABSORBING MONOMER. THESE DEVICES, PREVIOUSLY CLEARED FOR DAILY WEAR UNDER K020392, WILL BE MARKETED UNDER THE TRADE NAMES LISTED BELOW FOR THE FOLLOWING INDICATIONS FOR USE:FREQUENCY 55 UV AND FREQUENCY 55 UV ASPHERIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NOT APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. FREQUENCY 55 UV TORIC LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA, HYPEROPIA, AND ASTIGMATISM) IN APHAKIC AND NOT APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENSES MAY BE WORN BY PERSONS WHO HAVE ASTIGMATISM OF 12.00 DIOPTERS OR LESS. FREQUENCY 55 UV MULTIFOCAL LENSES ARE INDICATED FOR DAILY WEAR AND EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THEY ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT-APHAKIC PERSONS WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA AND ARE PRESBYOPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELP PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION INTO THE CORNEA AND THE EYE. NOTE: ONLY CHEMICAL (NOT HEAT) AND HYDROGEN PEROXIDE DISINFECTION SYSTEMS MAY BE USED WITH FREQUENCY 55 UV LENSES. FREQUENT/PLANNED REPLACEMENT WHEN PRESCRIBED FOR...
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