Duns Number:028594987
Device Description: Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available Paraperm® O2 (pasifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The Paraperm® O2 rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate.The Paraperm® O2 rigid gas permeable tinted lenses offer a handling aid for locating the lens.
Catalog Number
-
Brand Name
Paraperm O2
Version/Model Number
Paraperm O2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HPX
Product Code Name
Lens, Contact (Polymethylmethacrylate)
Public Device Record Key
ce284c96-5a91-42db-8f6e-2fce2368e05a
Public Version Date
March 23, 2021
Public Version Number
5
DI Record Publish Date
February 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| 3 | A medical device with high risk that requires premarket approval | 6 |