Product code QUR— Ophthalmic

“Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842.”

FDA has cleared 1 device under product code QUR, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Essilor Of America, Inc.1 clearance

• DEN250016 — Essilor® Stellest®Essilor Of America, Inc.·2025-09-25