Paragon HDS - Paragon HDS® (paflufocon B) rigid gas permeable - Paragon Vision Sciences, Inc.

Duns Number:028594987

Device Description: Paragon HDS® (paflufocon B) rigid gas permeable contact lenses for daily wear are availabl Paragon HDS® (paflufocon B) 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 tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in 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 Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.

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More Product Details

Catalog Number

-

Brand Name

Paragon HDS

Version/Model Number

Paragon HDS

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

HQD

Product Code Name

Lens, Contact (Other Material) - Daily

Device Record Status

Public Device Record Key

be87357b-fde5-4264-a102-37f4d412be62

Public Version Date

March 23, 2021

Public Version Number

4

DI Record Publish Date

March 23, 2018

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