Paragon Z CRT - Paragon Z CRT contact lenses are manufactured - Paragon Vision Sciences, Inc.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

NUU

Product Code Name

Lens, Contact, Orthokeratology, Overnight

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARAGON VISION SCIENCES, INC." Characteristics
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