Duns Number:936888460
Device Description: 30 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, 30 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, immersed in 0.9% buffered saline.Indication for use: The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Catalog Number
-
Brand Name
FreshKon® 1-Day (Etafilcon A)
Version/Model Number
Alluring Eye, Colors Fusion,Mosaic
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPL
Product Code Name
Lenses, Soft Contact, Daily Wear
Public Device Record Key
a11dcd98-7274-4f28-86f9-986826affed7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-