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Paraperm EW

FDA UDI

Class III (US FDA UDI)

by Paragon Vision Sciences

Identity

Trade Name
Paraperm EW FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Paraperm® EW (pasifocon C) 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 clear and tinted versions. Paraperm® EW 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 clear and 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 Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens. FDA UDI
Model / Reference
Paraperm EW FDA UDI
Description
Paraperm® EW (pasifocon C) 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 clear and tinted versions. Paraperm® EW 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 clear and 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 Paraperm® EW rigid gas permeable contact lens material is a thermoset copolymer derived from siloxane and methylmethacrylate. The Paraperm® EW rigid gas permeable tinted lenses offer a handling aid for locating the lens. FDA UDI

Identifiers

Primary DI / UDI-DI
B22203 FDA UDI
FDA Product Code
MWL FDA UDI
HQD FDA UDI
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
886.5916 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rigid-gas-permeable corrective contact lens, daily-wearRigid-gas-permeable corrective contact lens, extended-wear

Paraperm EW by Paragon Vision Sciences — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, extended-wear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon Vision Sciences

Sources (1)

  • FDA UDI d5978026-dd03-41e0-92c1-1d539463ea73 33 fields · synced May 31, 2026