SportSight GP

Basic Information

• Brand Name: SportSight GP
• Primary DI: B22215
• Version / Model: SportSight GP
• Company Name: Paragon Vision Sciences, Inc.
• Labeler DUNS: 028594987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-23
• Public Version: 5
• Public Version Date: 2026-03-17
• Public Version Status: Update
• Public Device Record Key: a682732f-ba80-4f68-a165-4800dfa82b53

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	886.5916	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47840	Rigid-gas-permeable corrective contact lens, daily-wear, non-customized	A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B22215	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K993586	000