SUNREEVE CO., LTD.

SunReeve Co., Ltd. specializes in spectacle frames, specifically the KEN OKUYAMA series. These devices are designed for optical and non-prescription eyewear, intended to correct or enhance vision without requiring medical intervention. They fall under the category of vision correction aids, which are commonly used for general vision support.

SunReeve Co., Ltd. is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for markets that require domestic production or distribution.

SunReeve Co., Ltd.’s spectacle frames, including the KEN OKUYAMA series, are classified as Class I medical devices under FDA regulations. This classification applies to low-risk devices where general controls (like good manufacturing practices) are sufficient for ensuring safety and effectiveness. Class I devices typically require less stringent premarket review compared to higher-risk categories.

Yes, SunReeve Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and market surveillance purposes. Listing in the UDI database is a requirement for Class I devices under FDA regulations.

Spectacle frames, including the KEN OKUYAMA series, are classified as medical devices because they are intended to support or enhance vision when paired with lenses (prescription or non-prescription). While the frames themselves do not correct vision independently, they are designed to be part of a system (frame + lenses) that aids in vision correction or protection, aligning with FDA definitions for vision correction aids. This classification ensures compliance with safety and performance standards.