Get the free Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302 - accessdata fda

A summary of the 510(k) premarket notification for CooperVision's Proclear soft contact lenses, detailing the device identification, intended use, and substantial equivalence to predicate devices.

How to fill out proclear omafilcon a soft

How to fill out Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302

1. Begin by reviewing the 510(k) Summary K112302 document thoroughly.
2. Gather all necessary personal and prescription information.
3. Follow the predefined structure in the summary for consistency.
4. In section 1, provide the basic information about the device including its intended use.
5. Section 2 should include a description of the device including materials and design.
6. In section 3, detail the indications for use of the contact lenses.
7. Section 4 requires a comparison with a legally marketed predicate device, highlighting similarities and differences.
8. Outline any clinical studies or tests conducted in section 5, providing results and findings.
9. Include labeling information that meets regulatory requirements in section 6.
10. Finally, proofread your summary for accuracy and completeness before submission.

Who needs Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

1. Individuals with vision correction needs, particularly those suffering from dry or uncomfortable eyes.
2. People seeking a soft contact lens option that provides extended wear comfort.
3. Patients who are suitable for contact lenses and want an alternative to glasses.

People Also Ask about

Are Proclear lenses good?

Are Proclear contacts good? Proclear monthly contact lenses are comfortable and consistent for 30 days; they keep your eyes hydrated to promote comfort and are a great value option. They work for both short and long-sighted wearers, ensuring consistency for most people.

Is Omafilcon a silicone hydrogel?

Briefly, samfilcon A is a silicone hydrogel fabricated from a proprietary siloxane macromer and NVP monomer. The lens material was designed to polymerize in two kinetic phases, with the rapid formation of a silicone network, followed by the later formation of a PVP internal wetting agent.

How long can you wear Proclear contacts?

Proclear contact lenses are monthly use; they can be worn for up to 30 days, as long as they are removed, cleaned, and stored correctly overnight. These lenses offer comfort and consistency over 30 days to ensure that wearers get the highest efficiency and clarity.

How do Proclear multifocal lenses work?

Proclear multifocal lenses focus light from both near and far distances to the back of the eye, creating the clearest possible image. This unique system uses two different, yet complementary, lenses that work together to provide clear vision near, far, and in between.

What is omafilcon A?

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in non-aphakic persons with non-diseased eyes.

Is samfilcon a silicone hydrogel?

Disadvantages: Adaptation: Some people may find it difficult to adjust to the difference in visual input between the two eyes. Reduced Depth Perception: Wearing monovision contact lenses may lead to a reduction in depth perception, making activities such as driving more challenging.

What are the disadvantages of monovision contact lenses?

Due to their improved comfort and ease of use, hydrogel lenses have made disposable contacts the first choice for both eye doctors and their patients. When it comes to dry and sensitive eyes, hydrogel material is frequently the best option due to its particular biocompatibility with the human eye.

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What is Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302 is a regulatory submission to the FDA that provides evidence the Proclear contact lenses are safe and effective for use. It outlines the product's specifications, intended use, and comparison to existing devices.

Who is required to file Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

Manufacturers of the Proclear (omafilcon A) Soft Contact Lenses are required to file the 510(k) Summary K112302 with the FDA to seek clearance for marketing the lenses in the United States.

How to fill out Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

Filling out the Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302 involves providing detailed information about the product, including its description, indications for use, design, manufacturing processes, and data from clinical trials that support its safety and effectiveness.

What is the purpose of Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

The purpose of Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302 is to demonstrate that the lenses are substantially equivalent to previously marketed devices and to obtain FDA clearance for their commercial distribution in the U.S.

What information must be reported on Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302?

The information required on the Proclear (omafilcon A) Soft Contact Lenses 510(k) Summary K112302 includes the device name, manufacturer information, intended use, product specifications, and results of any applicable testing or clinical studies.