Yes — FDA classifies all contact lenses, including purely cosmetic plano lenses with no refractive correction, as medical devices subject to premarket notification (510(k)) or approval requirements. Importers of decorative lenses must ensure the product has valid FDA clearance and that it is sold only through licensed eye-care professionals or with a valid prescription, per the Fairness to Contact Lens Consumers Act.

FDA requires that contact lens labeling include the device name, manufacturer information, lens parameters (base curve, diameter, power), material name, wearing schedule, and care instructions, among other elements. Shipments with non-compliant or foreign-language-only labeling may be detained at the port of entry, so importers should verify label compliance before the goods ship.