Fluoroperm 92

GUDID B22204

FluoroPerm® 92 (paflufocon A) 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. FluoroPerm 92 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 FluoroPerm® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.

PARAGON VISION SCIENCES, INC.

Rigid-gas-permeable corrective contact lens, daily-wear

• Primary Device ID: B22204
• NIH Device Record Key: ed1bdc6a-f318-49f7-b135-627c793a7897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluoroperm 92
• Version Model Number: Fluoroperm 92
• Company DUNS: 185530029
• Company Name: PARAGON VISION SCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B22204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052983

FDA Product Code

• MWL: Lens,Contact(Rigid Gas Permeable)-Extended Wear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-06
• Device Publish Date: 2018-03-23

Devices Manufactured by PARAGON VISION SCIENCES, INC.

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