Paragon CRT - Paragon CRT® Contact Lenses are manufactured from - Paragon Vision Sciences, Inc.

Duns Number:028594987

Device Description: Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). The lenses Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B). 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”. Paragon CRT® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, violet and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Violet No. 2 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

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More Product Details

Catalog Number

-

Brand Name

Paragon CRT

Version/Model Number

Paragon 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

-

Product Code Details

Product Code

NUU

Product Code Name

Lens, Contact, Orthokeratology, Overnight

Device Record Status

Public Device Record Key

fd6fa2a6-9d11-4060-97ce-e661f186d4c7

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