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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.
 
DeviceHYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantThe Cooper Companies
6150 Stoneridge Mall Rd.
Suite 370
Pleasanton, CA 94588
PMA NumberP890023
Supplement NumberS016
Date Received08/18/2004
Decision Date09/24/2004
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS: HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THEY ARE ALSO INDICATED FOR EXTENDED WEAR UP TO 7 DAYS/6NIGHTS. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENSES FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WEAR. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT/ PLANNED REPLACEMENT, THE LENSES MAY BE DISINFECTED USING A CHEMICAL OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE DEVICE HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.
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