Yes — FDA treats all contact lenses, including purely cosmetic or 'plano' lenses with no vision correction, as Class II or Class III medical devices. They require 510(k) clearance and must be sold through licensed eye-care practitioners. Importers of decorative lenses who attempt to market them as cosmetics rather than devices risk FDA detention and refusal of entry.

Complete spectacles (frames fitted with finished lenses) are classified under a different HTS heading than unfinished or uncut ophthalmic lens blanks. The distinction matters because duty rates differ and, for prescription lenses, the degree of finishing affects whether the article is considered a semi-manufacture or a finished good. Importers should confirm the processing state of lenses at time of importation to ensure correct classification.