Duns Number:936888460
Device Description: Two sterile daily wear soft contact lenses, 45% methafilcon A, 55% water, immersed in 0.9% Two sterile daily wear soft contact lenses, 45% methafilcon A, 55% water, immersed in 0.9% buffered saline.Indication for use: The FreshKon® Contact Lens is indicated for daily wear for the correction of refractive ametropia(myopia) in aphakic or not‐aphakic persons with non‐diseased eyes. The lens may be disinfected using a chemical disinfection system.Eye Care Professionals may prescribe the lens for frequent replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE) When prescribed for frequent replacement wear,the lens may be disinfected using a chemical disinfection system.
Catalog Number
-
Brand Name
FreshKon® (Methafilcon A)
Version/Model Number
Alluring Eye, Mosaic,Colors Fusion
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
-
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
3682b94f-8934-4cdd-84a6-08f0ed5eb2b5
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
-