AQUAIR (Enfilcon A) Soft (Hydrophilic) Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071736 FDA 510(k)
- FDA Product Code
- LPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AQUAIR (Enfilcon A) Soft (Hydrophilic) Contact Lens is a Group I, daily wear silicone hydrogel contact lens designed for optical correction and vision enhancement. Its material, enfilcon A, combines silicone macromers with other monomers to achieve high oxygen permeability (Dk), supporting prolonged wear comfort and corneal health. The lens includes an integrated phthalocyanine blue tint for improved visibility during handling and a UV-blocking additive to protect the eye from ultraviolet radiation.
Prescribed for daily wear, this lens may be used in either single-use disposable or planned replacement regimens, with disinfection via chemical or hydrogen peroxide systems when applicable. Supplied as a sterile, single-use device, it adheres to FDA 510(k) clearance under product code LPL and falls under Class II regulatory classification. Available in multiple FEI numbers for various prescriptions, it requires proper storage in a clean, dry environment to maintain sterility and performance.
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: Aquair (Enfilcon A) Soft (Hydrophilic) Contact Lens, PDF CooperVIsloc*Kon7 /2?36, aquair enfilcon a soft hydrophilic contact lens, AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) ... (K071736) - FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071736 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K071736 24 fields · synced Sep 20, 2026