HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P890023 S016

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.

Pre-market Approval Supplement Details

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.

DeviceHYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantTHE COOPER COMPANIES
Date Received2004-08-18
Decision Date2004-09-24
PMAP890023
SupplementS016
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address THE COOPER COMPANIES 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P890023Original Filing
S049 2022-08-29 30-day Notice
S048 2022-04-26 30-day Notice
S047 2020-09-25 30-day Notice
S046
S045 2020-08-24 30-day Notice
S044 2020-08-20 30-day Notice
S043 2020-08-03 30-day Notice
S042 2020-01-15 30-day Notice
S041
S040 2019-12-03 30-day Notice
S039 2019-10-15 30-day Notice
S038 2019-08-13 30-day Notice
S037 2019-02-26 30-day Notice
S036 2019-02-08 30-day Notice
S035 2018-08-09 Normal 180 Day Track No User Fee
S034 2018-06-18 Real-time Process
S033 2018-06-15 Real-time Process
S032 2018-04-05 Normal 180 Day Track No User Fee
S031 2018-03-16 135 Review Track For 30-day Notice
S030 2018-01-16 135 Review Track For 30-day Notice
S029 2017-10-24 30-day Notice
S028 2017-08-04 Real-time Process
S027 2017-01-30 30-day Notice
S026 2017-01-08 30-day Notice
S025 2016-04-13 Normal 180 Day Track No User Fee
S024 2015-12-22 30-day Notice
S023 2015-07-02 30-day Notice
S022 2014-09-08 Normal 180 Day Track No User Fee
S021 2013-11-13 135 Review Track For 30-day Notice
S020 2013-11-12 30-day Notice
S019 2013-07-22 30-day Notice
S018 2011-11-01 30-day Notice
S017 2010-04-26 135 Review Track For 30-day Notice
S016 2004-08-18 Real-time Process
S015 2004-07-02 Normal 180 Day Track No User Fee
S014 2003-12-22 Normal 180 Day Track No User Fee
S013 2002-01-18 Normal 180 Day Track
S012
S011 2001-07-20 Normal 180 Day Track
S010
S009 1999-09-17 Normal 180 Day Track
S008 1999-07-29 30-day Notice
S007 1999-04-20 Real-time Process
S006 1996-02-13 Normal 180 Day Track
S005 1995-10-23 Normal 180 Day Track
S004 1995-10-02 Normal 180 Day Track
S003 1995-09-29 Normal 180 Day Track
S002 1993-05-24 Normal 180 Day Track
S001 1990-10-31 Normal 180 Day Track

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