Kolplast CI Ltda

Kolplast CI Ltda manufactures the KOLPLUX System, a medical device designed for a specific clinical application. While the exact purpose isn’t detailed, the system is likely intended for use in surgical or diagnostic settings, such as illumination, imaging, or procedural support. The company specializes in this particular product line.

Kolplast CI Ltda is based in the United States. The company’s device, the KOLPLUX System, is classified as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires compliance with specific controls to ensure safety and effectiveness. This classification aligns with the FDA’s 510(k) clearance pathway.

The KOLPLUX System manufactured by Kolplast CI Ltda is listed in the FDA’s 510(k) clearance registry. This registry tracks devices that have undergone the 510(k) premarket notification process, demonstrating that the device meets applicable regulatory requirements before being marketed in the U.S.

The KOLPLUX System is classified as a Class II device by the FDA. This classification is based on the device’s intended use and risk level—Class II devices require special controls in addition to general controls to ensure their safety and performance. The classification helps determine the regulatory pathway and compliance requirements for the device.