510(k) DEN250016

Essilor® Stellest® by Essilor Of America, Inc. — Product Code QUR

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 25, 2025
Date Received: April 28, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Device Class: Class II
Regulation Number: 886.5845
Review Panel: OP
Submission Type

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.