What Does "FDA Cleared" Mean for Colored Contact Lenses?

What Is FDA Clearance?

In the United States, contact lenses are classified as medical devices. Before they can be sold legally, the manufacturer must demonstrate that the product is safe and performs as intended.

FDA Cleared means the product has undergone a 510(k) review, where the FDA evaluates whether the device is substantially equivalent to an already‑approved medical device.

This process confirms that:

• The lens material is safe for contact with the eye.

• The manufacturing process meets medical‑grade standards.

• The product labeling provides accurate instructions and warnings.

Why FDA Clearance Matters for Colored Contacts

Colored contacts—including cosmetic, plano, and non‑prescription designs—must meet the same safety requirements as vision‑correcting lenses. FDA clearance helps ensure:

1. Safe Materials and Pigments

Approved lenses use colorants that do not directly touch the eye, preventing irritation or abrasion.

2. Reliable Manufacturing Standards

This includes cleanroom environments, quality control, and sterility assurance.

3. Accurate Usage Instructions

FDA‑compliant packaging clarifies how to clean, store, and use the lenses safely.

Are Eyemoody Colored Contacts FDA Cleared?

Yes! Eyemoody sources lenses from manufacturers that meet FDA 510(k) clearance requirements for soft cosmetic lenses. This ensures users can enjoy FDA cleared colored contacts that meet recognized safety and quality standards.

What FDA Clearance Does Not Mean

• It does not replace professional eye exams.

• It does not allow extended wear unless specified.

• It does not guarantee suitability for every individual.

How to Buy Colored Contacts Online Safely

To ensure you’re purchasing safe circle lenses, follow these guidelines:

• Choose brands that offer FDA cleared colored contacts.

• Avoid unregulated sellers or cosmetic-only retailers.

• Follow cleaning and replacement schedules strictly.

• Never share lenses with others.

Conclusion

Understanding “FDA Cleared” helps you shop with confidence. Eyemoody’s commitment to compliant manufacturing means you can enjoy high‑quality, visually stunning lenses while prioritizing safety. When used properly, colored contacts can be a safe and exciting way to enhance your look.