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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
PMA NumberP890023
Supplement NumberS016
Date Received08/18/2004
Decision Date09/24/2004
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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.