Identity
- Trade Name
- PARAPERM O2 CONTACT LENS FDA PMA
- Generic Name
- Lens, contact (polymethylmethacrylate) FDA PMA
Identifiers
- PMA Number
- P820063 FDA PMA
- FDA Product Code
- HPX FDA PMA
Classification
- Device Class
- U FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S011 FDA PMA
The Paraperm O2 Contact Lens is a rigid gas permeable contact lens classified as a Lens, Contact (Polymethylmethacrylate). It is designed for daily wear and features spherical, aspheric, bifocal, toric, or bitoric anterior/posterior surfaces, available in clear or tinted versions. The material is a thermoset copolymer derived from siloxane and methylmethacrylate, providing oxygen permeability for extended comfort.
This device is supplied as a single-use or reusable lens, depending on the specific prescription and handling instructions. It is regulated under FDA_PMA authorization (PMA number P820063), with supplementary approvals (e.g., S011). The lenses are intended for ophthalmic use and must be handled according to clinical guidelines to ensure proper fit and hygiene. No MRI safety information is specified, and storage conditions align with standard contact lens care protocols.
Frequently asked questions
What types of vision corrections can the Paraperm O2 Contact Lens address, and how does its design support comfort during wear?
The Paraperm O2 Contact Lens is designed to address spherical, astigmatic (toric), presbyopic (bifocal/bitoric), and complex vision needs with spherical or aspheric surfaces. Its material—a thermoset copolymer of siloxane and methylmethacrylate—enhances oxygen permeability, reducing dryness and improving comfort for daily wear. The lens is available in clear or tinted versions to suit patient preferences while maintaining optical clarity.
Are these lenses single-use or reusable, and what considerations should be taken into account when deciding between the two options?
The Paraperm O2 Contact Lens is available in both single-use and reusable forms, depending on the specific prescription and handling instructions provided. Reusable lenses require strict adherence to cleaning, disinfection, and storage protocols to prevent contamination and maintain hygiene, while single-use lenses eliminate these concerns but may increase cost per wear. Always follow the manufacturer’s guidelines to ensure proper fit, safety, and longevity.
What storage conditions should be followed to maintain the integrity of the Paraperm O2 Contact Lens before use?
The Paraperm O2 Contact Lens should be stored according to standard contact lens care protocols, which typically include keeping it in a clean, dry, and sealed container away from direct sunlight or extreme temperatures. Avoid exposure to moisture or chemicals, and ensure the lens case is properly disinfected if using a reusable version. Always refer to the accompanying instructions for specific storage recommendations.
How was the regulatory approval process for this device structured, and what does the PMA authorization indicate about its oversight?
The Paraperm O2 Contact Lens received FDA approval through a Premarket Approval (PMA) application (PMA number P820063), which is the highest level of regulatory review for medical devices. This process involves rigorous clinical testing and evaluation by the FDA to ensure safety and effectiveness. The supplementary approval (S011) suggests additional modifications or updates were later validated under the same oversight. The device is classified under U (Unclassified) in the FDA’s system, with a product code of HPX for ophthalmic use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Paraperm O2 Paraperm® O2 (pasifocon A) rigid gas… - FDA.report, PARAPERM O2 (PASIFOCON A) CONTACT LENS PMA P820063S046 - FDA.report, Paraperm O2 - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P820063 | U | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P820063 23 fields · synced Sep 18, 2026