Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042824 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)
This device is a Soft Contact Lens, Daily Wear (product code LPL), classified under FDA’s Class II – Special Controls. It is designed for the correction of refractive ametropia, including myopia and hyperopia, using a hydrophilic polymacon material. The lens is intended for daily wear and provides clear vision through optical correction while maintaining ocular comfort.
The Frequency 38 and Silver 07 lenses are supplied as single-use, non-sterile disposable contact lenses, intended for professional fitting by eye care practitioners. They are regulated under FDA’s 510(k) clearance (K042824) and comply with 21 CFR 886.5925 for ophthalmic devices. Available in multiple base curve and diameter sizes, they require proper handling and storage in sterile packaging to prevent contamination. No MRI safety restrictions are specified.
Frequently asked questions
What is the Frequency 38 & Silver 07 Soft Contact Lens designed for?
This device is designed to correct refractive ametropia, including myopia (nearsightedness) and hyperopia (farsightedness). It uses a hydrophilic polymacon material to provide clear optical correction while maintaining ocular comfort during daily wear. The lenses are intended for professional fitting by eye care practitioners to ensure proper prescription and fit.
Are these lenses single-use or reusable?
The Frequency 38 & Silver 07 Soft Contact Lenses are supplied as single-use, disposable lenses. This design reduces the risk of contamination and infection, as each lens is intended for one-time use only. Proper handling and disposal after use are recommended to maintain hygiene and safety.
What is the sterility status of these lenses?
These lenses are non-sterile at the time of packaging. They are supplied in sterile packaging to minimize contamination risk, but they are not sterile as a final product. Eye care practitioners must ensure proper handling and storage to prevent contamination before use.
What base curve and diameter sizes are available?
The Frequency 38 & Silver 07 lenses are available in multiple base curve and diameter sizes, as indicated by the listed FEI numbers (e.g., 3015533540, 3012546757). These variations allow for custom fitting to accommodate different corneal shapes and prescriptions. Eye care professionals select the appropriate size based on patient-specific measurements.
How should these lenses be stored?
The lenses must be stored in their original, unopened sterile packaging to prevent contamination. Once removed from packaging, they should be used immediately and disposed of after a single use. Avoid exposing the lenses to moisture, dust, or direct sunlight, as this could compromise their integrity or introduce microbial contamination.
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: K042824 FDA 510(k) - FREQUENCY 38 AND SILVER 07 (POLYMACON) ..., Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens ..., frequency 38 and silver 07 polymacon soft hydrophilic contact lens, Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042824 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K042824 24 fields · synced Oct 1, 2026