• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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.
 
Trade NameACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantVISTAKON
PMA NumberN18033
Supplement NumberS035
Date Received01/29/2001
Decision Date04/12/2001
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an etafilcon a soft (hydrophilic) contact lens for extended wear with uv blocker and the follwoing listed color additives: iron oxide black, iron oxide brown, iron oxide red, iron oxide yellow, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green and vat orange 1. The device will be marketed with the following trade names and indicatnions: the acuvue (r) 2 colours contact lenses are indicated for daily wear to enhance or later the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1. 00d or less of astigmatism. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) bifocal contact lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0. 75d of astigmatism or less. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) toric contact lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10. 00d of astigmatism or less. The acuvue(r) 2 colours (etafilcon a) soft (hydrophilic) toric-bifocal contact lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased who may have 10. 00d or astigmatism or less. Acuvue(r) 2 colours uv blocking contact lenses help protect against transmissino of harmful uv radiatino to the cornea and into the eye. The acutvue(r) 2 colours contact lenses may be prescribed for daily wear. Eye care practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "wearing schedule". ) when prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfectio.
-
-