INTEROJO INC.

Interojo Inc. specializes in soft corrective contact lenses, specifically designed for daily-wear and daily-disposable use. These lenses are intended for vision correction and include variants like HAPA KRISTIN, Impressions, Iris, and Miz. The company focuses exclusively on this category of devices, ensuring compliance with regulatory standards for eyewear.

Interojo Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these lenses as Class II, indicating a moderate level of control is required to ensure their safety and effectiveness. This classification helps streamline the regulatory process while maintaining oversight.

Interojo Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices, allowing healthcare providers, regulators, and patients to access critical information about the devices’ authorization status and compliance with U.S. regulations.

Interojo Inc.’s soft corrective contact lenses are classified as Class II devices by the FDA. This classification means they pose a moderate risk and require special controls beyond general controls to ensure their safety and performance. The classification helps determine the regulatory pathway—such as 510(k) clearance or UDI compliance—ensuring the devices meet necessary standards before reaching the market.