Quality Assurance

Our Commitment to Your Vision and Safety

we ensure that every lens we sell meets the rigorous safety standards required for Class II Medical Devices.

1. FDA 510(k) Premarket Notification Our lenses are manufactured under the FDA 510(k) clearance number K220143. This technical clearance covers the material (Polymacon) and design specifications used in our MIIEMO product lines, ensuring they are substantially equivalent to legally marketed devices in the United States.

2. Brand and Manufacturer Relationship: MIIEMO is a proprietary brand manufactured by our production partner, Shenzhen Dasicheng Optical Technology Co., Ltd. MIIEMO products are officially listed on the manufacturer's FDA medical device list and accompanied by Premarket Notification K220143.

3. Safety & Technology

• Sandwich Technology: To protect your eyes, MIIEMO lenses use a multi-layer printing process that keeps color pigments safely tucked between two layers of clear lens material.
• Polymacon Material: Known for its durability and comfort, this material is FDA-compliant and provides a consistent wearing experience.
• Quality Management: Our facility is ISO 13485 certified, reflecting our commitment to high-standard medical device manufacturing.

4. Product Verification You can verify these credentials on the official FDA website:

510(k) Clearance: Search for K220143 in the FDA 510(k) database.

Establishment Registration: Search for "Shenzhen Dashicheng" via the FDA Establishment Registration & Device Listing database.