FSA 38

GUDID B22211

FSA 38 (paflufocon E) 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 in clear and tinted versions. 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 the cornea. The FSA 38 (paflufocon E) rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomer.

PARAGON VISION SCIENCES, INC.

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• Primary Device ID: B22211
• NIH Device Record Key: 5e9d849e-3024-4d31-acbe-817f7bf1cc71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSA 38
• Version Model Number: FSA 38
• 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	B22211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984436

FDA Product Code

• HQD: Lens, Contact (Other Material) - Daily

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: 2019-04-08
• Device Publish Date: 2018-03-16

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