CE Certified non prescription colored contact lenses Manufacturer & Factory

Non-prescription cosmetic contact lenses are regulated as medical devices in most major markets. For the European Union, products must comply with CE certification under the EU Medical Devices Regulation (MDR 2017/745), supported by ISO 13485 Quality Management System certification. In the United States, soft contact lenses require FDA 510(k) clearance or equivalent registration, regardless of whether they correct vision or are purely cosmetic. Mylensora provides complete technical dossiers, batch sterility certificates, and ISO documentation to support your local registration process.

We utilize high-precision automated cast-molding systems and automated spectrophotometric color matching software. Our 3-Layer Bio-Sandwich technology controls pigment density at the micron level, preventing color deviation between batches. Every batch undergoes automated optical inspection (AOI) to verify pattern centration, diameter consistency, and color chromaticity before entering sterilization chambers.

For standard factory color patterns with customized secondary packaging (outer paper gift box and labeled blister caps), our MOQ starts as low as 500 to 1,000 pairs per shade. For fully custom ODM projects requiring bespoke iris pattern creation and customized lens parameters (base curve, diameter, water content), MOQs are typically structured around master batch casting cycles (approx. 5,000 to 10,000 pairs).

Our contact lenses are sealed in medical-grade aluminum blister packaging containing buffered saline solution and undergo moist-heat steam autoclaving or validated gamma sterilization processes. This yields a guaranteed 5-year shelf life from the date of manufacture when stored in cool, dry conditions away from direct sunlight.

Yes. Mylensora operates dual-capability production lines. Almost all cosmetic color patterns in our catalog can be produced either as non-prescription (Plano 0.00 D) or as prescription colored lenses ranging from -0.50 D to -10.00 D in 0.25 D or 0.50 D increments, allowing your brand to serve both fashion-only consumers and vision-correction patients seamlessly.

For in-stock designs with standard packaging, orders can be dispatched within 7 to 10 business days. For customized private label OEM orders involving custom box printing and specialized blister aluminum foils, production lead times typically range from 25 to 35 calendar days following artwork approval and sample sign-off.