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SportSight GP

FDA UDI

Class II (US FDA UDI)

by Paragon Vision Sciences

Identity

Trade Name
SportSight GP FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
SportSight GP (paflufocon C) intensely tinted 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, posterior or bitoric surfaces. the posterior curve is selected so as to properly fit an individual eye and the anterior curve 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 cornea. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lens material is a thermoset copolymer dervied from fluorosilicone acrylate monomer. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable lenses deliver substantial attenuation of bright light and resultant reduction of glare. SportSight GP lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. All environmental UV radiation (including UVA and UVB) is reduced to less than 1% transmission. Blue light (below 500nm) is reduced to less than 10% in SportSight yellow and SportSight brown or 36% in SportSight gray. FDA UDI
Model / Reference
SportSight GP FDA UDI
Description
SportSight GP (paflufocon C) intensely tinted 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, posterior or bitoric surfaces. the posterior curve is selected so as to properly fit an individual eye and the anterior curve 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 cornea. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable contact lens material is a thermoset copolymer dervied from fluorosilicone acrylate monomer. The SportSight GP (paflufocon C) intensely tinted rigid gas permeable lenses deliver substantial attenuation of bright light and resultant reduction of glare. SportSight GP lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. All environmental UV radiation (including UVA and UVB) is reduced to less than 1% transmission. Blue light (below 500nm) is reduced to less than 10% in SportSight yellow and SportSight brown or 36% in SportSight gray. FDA UDI

Identifiers

Primary DI / UDI-DI
B22215 FDA UDI
510(k) Number
K993586 FDA UDI
FDA Product Code
HQD FDA UDI
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI

Classification

Device Class
Class II 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-wear

SportSight GP by Paragon Vision Sciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, daily-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 a682732f-ba80-4f68-a165-4800dfa82b53 34 fields · synced Jun 1, 2026