Your Essential Guide to Best FDA Approved Colored Contacts

FDA approved colored contacts are trending right now, and you can see celebrities and influencers rocking this eye-catching look. These fashionable accessories aren't just about style - they're medical devices that need proper oversight.

Colored contacts let you change your eye's appearance temporarily. You can wear them daily or save them for special occasions. The American Academy of Ophthalmology (AAO) says you should ask an eye care professional before buying colored contacts, even if your vision is perfect. This makes sense because FDA approved colored contacts must meet strict safety standards. Unregulated options from gray markets don't have these approvals and can be dangerous.

The safest colored contacts need a prescription by law. Coleyes leads the market and gives you nine stunning colors to choose from. These lenses let plenty of oxygen reach your eyes.

Why FDA Approval Matters for Colored Contacts

The FDA takes colored contact lenses seriously, and with good reason too. These eye-changing accessories aren't just cosmetic products - they're regulated medical devices that touch one of your most sensitive organs. Safety regulations behind these products play a vital role if you want to change your eye color safely.

What does FDA approval mean?

All contact lenses are classified as medical devices by the FDA, whatever their purpose - vision correction or eye color change. This classification puts them under strict regulatory control to meet safety standards.

Many people don't know that contact lenses receive FDA clearance rather than FDA approval. Manufacturers must submit a premarket notification (known as a 510(k)) to show their product matches legally marketed devices. The FDA assigns Class II or Class III designations based on risk profile and intended use.

This clearance process makes sure products meet specific regulatory requirements for materials, manufacturing, and performance standards. FDA clearance means these lenses have passed safety and effectiveness tests according to set guidelines - you can trust their quality.

Risks of using non-FDA approved lenses

Using non-FDA approved colored contacts can be dangerous, way beyond the reach and influence of simple discomfort:

• Corneal damage: Poorly fitted or manufactured lenses can scratch your cornea (the eye's outer layer) and cause abrasions, ulcers, and permanent scarring.
• Severe infections: Non-approved lenses might contain bacteria that lead to serious infections like keratitis.
• Vision impairment: These unapproved products can affect vision quality or even cause blindness.
• Physical irritation: Decorative contacts are thicker, more rigid, and less breathable than regular lenses, which increases infection risk.
• Chemical exposure: Some colored contacts use dyes and chemicals that can harm your eyes.

Non-approved lenses don't fit your eye's unique shape, which creates an uneven surface against your cornea and causes painful scratches. Colored patterns printed on these lenses make the surface even more uneven, which adds to potential damage.

How to verify FDA approved contact lenses

You can check if your colored contacts have FDA clearance through these steps:

Consult eye care professionals – Your optometrist or ophthalmologist can help you find safe, FDA-cleared decorative lenses. They'll fit them properly and recommend reliable products for your eyes.

Check purchasing requirements – Legal sellers must ask for a prescription - this applies to all contacts, including non-corrective colored lenses. Any seller who doesn't ask for your prescription breaks the law.

Avoid unauthorized sellers – Stay away from street vendors, beauty supply stores, flea markets, novelty shops, Halloween stores, convenience stores, or websites that don't need prescriptions. These unauthorized sellers often stock counterfeit or unapproved products.

Verify through official channels – FDA's online resources help confirm specific brands' clearance status. Trusted optical retailers usually stock only cleared lenses.

Note that selling contact lenses without requiring and verifying a prescription with your doctor breaks the law. Legitimate sellers will ask for your prescription and your doctor's contact information to verify.

Your vision and eye health deserve protection. Making FDA clearance a priority when choosing colored contacts isn't just about following rules - it's about keeping your eyes safe for years ahead.

How to Choose Safe Colored Contacts

Picking the right colored contacts takes more than just choosing a color you like. These medical devices sit right on your eyes, so you need to select them carefully for both safety and the look you want.

Prescription vs non-prescription colored contacts

Many people think colored contacts without vision correction don't need prescriptions. The FDA regulates all colored contacts as medical devices that need a prescription, whatever their purpose. Here's the main difference:

Non-prescription colored contacts (also called "plano" lenses) change your eye color but don't fix vision problems. You still need an eye doctor to fit these lenses properly since they touch your eyes directly.

Prescription colored contacts work double duty—they fix vision problems like nearsightedness or astigmatism and change your eye color. You'll get both better vision and a new look with these lenses.

The FDA's stance is clear: selling contact lenses without asking for a prescription breaks the law. This rule protects your eyes rather than making things difficult.

Consulting an eye care professional

You should see an optometrist or ophthalmologist before you get colored contacts. Your doctor will:

1. Take measurements to fit your lenses properly
2. Check how your eyes handle contact lenses
3. Look for any eye problems
4. Show you how to take care of your lenses

You can't skip this professional fitting. Poorly fitted lenses can hurt your eyes, cause infections, lead to pink eye, reduce vision, and could even make you blind. The exam costs between $100-$250, but it's worth it to protect your eyes.

Eye care professionals will give you a prescription with vital details like:

• Base curve (matches your cornea's shape)
• Diameter (lens size)
• Power (vision correction if needed)
• Brand recommendations

Avoiding counterfeit or unregulated sellers

Fake colored contacts flood the market today. U.S. Customs has grabbed thousands of illegal lenses worth almost half a million dollars. These unauthorized products often fail safety tests and can harm your eyes.

Don't buy colored contacts from:

• Street vendors or flea markets
• Beauty supply stores or salons
• Halloween or novelty shops
• Convenience stores
• Online stores that don't need prescriptions

These sellers usually skip asking for prescriptions—which breaks federal law. Counterfeit lenses might come from dirty factories, contain dangerous chemicals, or use poor materials that block oxygen from reaching your cornea.

You should buy FDA-approved colored contacts only from authorized sellers who verify your prescription with your doctor before shipping your order.

Safe colored contacts require three steps: get professionally fitted, get a valid prescription, and buy from trusted sources. Your eyes deserve proper care, and doing this will give a great color change while keeping your eyes healthy.

Best FDA Approved Colored Contact Brands (Expert Tested)

At Coleyes, we prioritize both safety and style when it comes to colored contact lenses. After consulting with eye care professionals and reviewing FDA records, we’ve curated a selection of premium FDA-approved colored contacts that cater to different preferences—whether you’re looking for natural enhancement, bold transformations, or UV protection.

Here’s why Coleyes stands out in the world of colored contacts:

Natural-Looking Color Blends

Our Hydrogel and Silicone Hydrogel lenses feature advanced tinting technology, ensuring seamless color transitions that mimic the natural iris. Whether you have light or dark eyes, our lenses enhance your look without appearing artificial.

All-Day Comfort & Breathability

With high water content (up to 55%) and oxygen permeability, Coleyes lenses keep your eyes moisturized and comfortable—even after 12+ hours of wear. Our SmartShield® Technology prevents protein buildup, reducing irritation.

UV Protection for Healthier Eyes

Many of our lenses include Class 1 or Class 2 UV blockers, shielding your eyes from harmful UVA/UVB rays—a must for outdoor wear.

Versatile Wear Options

Choose from:

✅ Daily disposables (perfect for travel or occasional wear)

✅ Monthly lenses (great for long-term color enhancement)

✅ Special-effect lenses (for cosplay and dramatic looks)

Designed for Different Eye Shapes

Whether you have Asian, deep-set, or round eyes, our lenses ensure a perfect fit with enhanced comfort.

Celebrity & Cosplay Favorite

Loved by makeup artists and influencers, Coleyes lenses deliver vibrant, high-pigment colors while maintaining a natural edge.

Types of FDA Approved Colored Contacts by Wear Duration

FDA-approved colored contacts give you multiple options for wear duration that match your lifestyle needs. Understanding these choices will help you pick the right type that works best for your eye health requirements and priorities.

Daily disposable lenses

Daily disposable colored contacts work for just one day before you throw them away. These fresh lenses each day mean you won't need to clean, disinfect, or store them. People with dry eyes often find daily lenses more comfortable because of their high water content.

Monthly lenses

Monthly colored contacts last up to 30 days when you take care of them properly. The silicone hydrogel material lets five times more oxygen reach your eyes than standard contacts. Coleyes shows this perfectly with its breathable material and 33% water content that stays comfortable all day. You'll need to take out these lenses every night to clean and store them.

Quarterly and yearly lenses

Quarterly colored contacts last three months with the right care. Coleyes gives you twelve FDA-approved shades. Yearly colored contacts can serve you for 12 months with proper maintenance, making them affordable. Notwithstanding that, but yearly lenses might start to wear down around month 8 or 10, even with excellent care.

Which type is right for you?

Your choice between wear durations depends on several things. Daily disposables excel in convenience and hygiene but cost more long-term. Monthly lenses strike a balance between convenience and cost if you don't mind regular cleaning. Quarterly and yearly options save you money if you wear them often and can handle the maintenance.

Your daily routine is a vital part of this choice. Daily lenses might work best if you only wear colored contacts now and then. Monthly or quarterly options usually make more sense for regular use. Your eyes' sensitivity could push you toward daily lenses since they don't collect deposits. A chat with your eye doctor can help you find the perfect duration based on your eye health, wearing patterns, and comfort needs.

Tips for Safe Use and Maintenance

FDA approved colored contacts last longer and keep your eyes healthy with proper care. These medical devices need special safety protocols that go beyond regular cosmetic products.

Proper cleaning and storage

Clean hands are essential - use soap and water before touching your colored contacts. Users with reusable lenses should put a few drops of recommended disinfecting solution and gently rub each lens for 20 seconds. Your lenses need proper storage in a clean case with fresh solution. Water or saliva should never touch your lenses since they contain harmful bacteria. A new case becomes necessary every three months. Fresh solution must always be used - never add new solution to old.

When to replace your lenses

Different lens types need different replacement schedules. Daily disposables are single-use only. Monthly lenses need replacement after 30 days from first use. Quarterly lenses work up to 3 months, while yearly lenses last 365 days with proper care. Lenses need fresh solution at least weekly, even with minimal wear. Time to throw them away once they reach their expiration date, regardless of how good they look.

Signs of irritation or infection

Take your colored contacts out right away if you notice redness, pain, excessive discharge, blurred vision, or extreme light sensitivity. Glasses become your best option until an eye care professional checks things out. The affected lenses should stay in their case - doctors might need to get into them later.

Travel and hygiene tips

Daily disposables make great travel companions since they eliminate cleaning needs. Your travel kit should include travel-sized solution. Water exposure raises infection risk, so contacts should come out before swimming or showering. Swimmers who need their lenses should wear goggles and throw away soft lenses after pool time.

Conclusion

Colored contacts are a great way to get a new look, but you need to think over more than just how they'll make you look. These eye-enhancing accessories are medical devices that need proper oversight, as we've shown throughout this piece. FDA approval is the life-blood of contact lens safety and protects you from potential sight-threatening issues that come with fake products.

You need a prescription and professional fitting for all colored contacts, whatever their purpose. This rule exists to protect you, not just as red tape. So, any seller offering lenses without asking for your prescription breaks the law and likely stocks products that could harm your eyes.

Your safety must come first at the time you use colored contacts. You can substantially cut down infection risks with proper cleaning, storage, and following replacement schedules. As with any eye irritation, quick removal helps prevent serious issues.

Colored contacts definitely add flair to your style choices, but they're not like other cosmetic products. These FDA approved accessories reshape the scene while you retain control of your eye health if you choose and use them right. Make sure to ask an eye care professional before buying - they'll guide you to the safest options for your unique eyes. Your vision deserves products that meet the highest safety standards.