LAGADO CORPORATION, THE

Lagado Corporation specializes in rigid-gas-permeable corrective contact lenses for daily wear, which are designed to improve vision by reshaping the cornea. They also produce hard corrective contact lenses, including models like PMMA-based designs, which are intended for long-term vision correction. These devices fall into two primary categories: daily-wear rigid-gas-permeable lenses and traditional hard contact lenses.

Lagado Corporation is based in the United States. Since the company operates within the US, its devices are subject to regulatory oversight by the FDA, including classification and listing requirements. The FDA’s Unique Device Identifier (UDI) database includes listings for its products, ensuring traceability and compliance with US regulatory standards.

Lagado Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the US, ensuring transparency and compliance with regulatory requirements. The UDI system helps healthcare providers and authorities verify device details, including classification and manufacturer information.

Lagado Corporation’s devices are classified as either Class II or Unclassified (U) under regulatory frameworks. Class II devices typically require special controls beyond general controls to ensure their safety and effectiveness, while Unclassified devices may have minimal regulatory requirements depending on their risk profile. The specific classification helps determine the level of oversight and documentation needed for each product.