510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250016Unknown

Essilor® Stellest®

Essilor of America, Inc., Dallas TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN250016 is the FDA 510(k) clearance record for Essilor® Stellest®, a class II device, cleared for Essilor Of America, Inc. on under FDA product code QUR (Prescription Spectacle Lenses To Reduce The Progression Of Myopia). FDA's definition for product code QUR reads: "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...". FDA records list one 510(k) clearance for Essilor Of America, Inc. As of , FDA records show no recalls naming DEN250016.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QUR Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Regulation
21 CFR 886.5845
Device class
Class II
Review panel
Ophthalmic
Applicant
Essilor Of America, Inc. 13455 Branchview Ln., Dallas TX
Third party review
No

Clearances, product code QUR

Trailing 12 months

FDA records hold no clearances under product code QUR in the trailing twelve months.

FDA records show no clearances under product code QUR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QUR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260