Identity
- Trade Name
- HYDRON HYDROPHILIC CONTACT LENS FDA PMA
- Generic Name
- Lenses, soft contact, daily wear FDA PMA
Identifiers
- PMA Number
- P780007 FDA PMA
- FDA Product Code
- LPL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S012 FDA PMA
The Hydron Hydrophilic Contact Lens is a soft contact lens designed for daily wear. According to the generic name and nomenclature, it falls under the category of 'Lenses, Soft Contact, Daily Wear,' intended for corneal or scleral application to correct refractive errors or improve vision.
These lenses are supplied as single-use or reusable, depending on the specific variant, and are regulated under FDA Premarket Approval (PMA) with PMA number P780007. They are classified as Class II medical devices under the FDA’s regulatory framework, adhering to the requirements outlined in regulation number 886.5925. No specific MRI safety or sterility details are provided in the data.
Frequently asked questions
Are these contact lenses designed for continuous wear or only daily wear as mentioned in the description?
The Hydron Hydrophilic Contact Lens is explicitly described as designed for daily wear only, not continuous wear. The generic name and nomenclature classify it under 'Lenses, Soft Contact, Daily Wear,' which aligns with its intended use for short-term, daily correction of refractive errors or vision improvement.
Do these lenses come in single-use or reusable options, and how should I determine which variant I need?
The Hydron Hydrophilic Contact Lens is available in both single-use and reusable variants, as noted in the description. To determine which variant suits your needs, consult your eye care professional. Single-use lenses are typically discarded after one wear, while reusable lenses are cleaned and stored for multiple uses. The specific variant (single-use or reusable) is not further detailed in the provided data, so professional guidance is recommended.
What regulatory pathway was followed for approval of this device, and what does that mean for its safety and efficacy?
The Hydron Hydrophilic Contact Lens was approved through the FDA Premarket Approval (PMA) pathway, with PMA number P780007. This pathway is reserved for higher-risk medical devices, ensuring rigorous review of clinical data to confirm safety and effectiveness. The device is classified as a Class II medical device under FDA regulations (886.5925), indicating it has undergone thorough scrutiny to meet performance standards for its intended use.
Are there any specific storage instructions provided for these lenses, or should I assume standard contact lens storage guidelines?
The provided data does not include explicit storage instructions for the Hydron Hydrophilic Contact Lens. As a general practice, reusable lenses should be stored in a clean, sealed contact lens case filled with fresh, multi-purpose contact lens solution. Single-use lenses should be stored in their original packaging until use. Always follow the manufacturer’s guidelines or consult your eye care professional for specific storage recommendations.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P780007 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P780007 24 fields · synced Sep 18, 2026