Duns Number:028594987
Device Description: Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses a Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone" and a non-curving “Landing Zone”.The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.Paragon Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
Catalog Number
-
Brand Name
Paragon Z CRT
Version/Model Number
Paragon Z CRT
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
P050031,P050031,P050031,P050031,P050031,P050031,P050031
Product Code
NUU
Product Code Name
Lens, Contact, Orthokeratology, Overnight
Public Device Record Key
015fc0c4-c456-478c-b620-e0d30b994702
Public Version Date
April 13, 2021
Public Version Number
1
DI Record Publish Date
April 05, 2021
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 |