VIZIONFOCUS INC.

VizionFocus Inc. specializes in soft corrective contact lenses, specifically daily-disposable silicone hydrogel (SiHy) lenses. These lenses are designed for extended wear and high oxygen permeability, ensuring comfort and vision correction for users. The company’s portfolio focuses exclusively on this category of devices.

VizionFocus Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies these lenses as Class II, indicating they pose moderate risk and require premarket notification (510(k)) clearance before commercialization. The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database for traceability.

VizionFocus Inc.’s devices are authorised via FDA 510(k) clearance and are included in the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance tracking for healthcare professionals and regulatory bodies. The UDI system helps identify and trace specific devices throughout their lifecycle.

The company’s soft corrective contact lenses are classified as Class II devices by the FDA. This classification is based on their intended use—providing vision correction—and their associated risk profile, which requires additional controls beyond general controls (e.g., special labeling, performance standards, or postmarket surveillance). Class II devices typically require a 510(k) clearance to demonstrate substantial equivalence to a predicate device.