FSA 52

GUDID B22214

FSA 52 (migafocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspher

PARAGON VISION SCIENCES, INC.

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• Primary Device ID: B22214
• NIH Device Record Key: 8a68f93e-656b-46b4-a2cb-452d1efd7cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSA 52
• Version Model Number: FSA 52
• 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	B22214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013310

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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-16

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