Essilor Stellest

Basic Information

• Brand Name: Essilor Stellest
• Primary DI: 03615024000034
• Version / Model: Myopia+Astigmatism
• Company Name: ESSILOR INTERNATIONAL
• Labeler DUNS: 277373213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-16
• Public Version: 1
• Public Version Date: 2025-10-24
• Public Version Status: New
• Public Device Record Key: 91d9c410-3cad-4304-a307-1533ce8b2938

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QUR	Prescription Spectacle Lenses To Reduce The Progression Of Myopia	Ophthalmic	886.5845	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35957	Prescription spectacle lens, custom-made	An ophthalmic lens made of glass or plastic that is manufactured in accordance with a specific patient prescription (custom-made) and intended to be worn in front of the eyes to correct the refractive errors of that patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615024000034	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN250016	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Sphere (D) Cylinder (D)