HDS HI 1.54 - HDS HI 1.54 (pahrifocon A) rigid gas permeable - Paragon Vision Sciences, Inc.

Duns Number:028594987

Device Description: HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut 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 as as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power in correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.The HDS HI 1.54 rigid gas permeable contact lens material is a thermoset copolymer derived from acrylated, silicone acrylate, and fluorosilicone acrylate monomers, dimers and oligomers. The HDS HI 1.54 rigid gas permeable tinted lenses offer a handling aid for locating the lens and may be plasma treated.

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More Product Details

Catalog Number

-

Brand Name

HDS HI 1.54

Version/Model Number

HDS HI 1.54

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

956c3702-0721-42ed-a4b7-99e07b8cdca7

Public Version Date

March 23, 2021

Public Version Number

5

DI Record Publish Date

February 02, 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