Are Colored Contacts Medical Devices in the US?

Yes—colored contacts are medical devices in the U.S., and that’s a good thing. FDA regulation protects consumers by ensuring safe materials, proper manufacturing, and accurate usage instructions. When you choose Eyemoody, you’re selecting lenses that align with these standards, helping you enjoy color-enhancing lenses with confidence.

Colored Contacts Are Medical Devices

In the U.S., the Food and Drug Administration (FDA) classifies all contact lenses—including cosmetic, plano, and non-prescription colored lenses—as Class II medical devices.

This classification applies regardless of:

• Whether the lenses correct vision

• Whether they are purely cosmetic

• Whether they are purchased in-store or online

What This Classification Means

1. FDA Review Is Required

Manufacturers must obtain FDA 510(k) clearance before lenses can be legally marketed. This ensures:

• Material safety (such as Polymacon or other approved hydrogels)

• Proper pigment encapsulation (e.g., Sandwich Technology)

• Accurate labeling and usage directions

2. Prescription Requirement

Even non-prescription colored contacts require a valid contact lens prescription in the U.S. This helps ensure:

• Proper fit

• Safe, appropriate use

• Reduced risk of infections or corneal injury

3. Regulated Manufacturing Standards

Manufacturers must follow strict quality control measures, including:

• Sterile production environments

• Biocompatible pigments

• Verified material performance

Safety Implications for Consumers

Because colored contacts are medical devices, users should:

• Purchase only from retailers offering FDA cleared colored contacts

• Avoid costume shops or unregulated online sellers

• Follow cleaning, handling, and replacement instructions carefully

Eyemoody’s Compliance

Eyemoody partners with FDA-cleared manufacturers that produce safe circle lenses using approved materials and pigment-sealing technologies. This ensures that our products meet U.S. safety requirements.