Essilor Stellest

Primary DI
03615024000027
Brand
Essilor Stellest
Company
ESSILOR INTERNATIONAL
Model
myopic correction
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
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QURPrescription Spectacle Lenses To Reduce The Progression Of Myopia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QURPrescription Spectacle Lenses To Reduce The Progression Of MyopiaOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250016000Essilor® Stellest®Essilor Of America, Inc.2025-09-25QUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03615024000027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615024000027036150240000273615024000027

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectacle lens, custom-madeAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
277373213
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03615020000397Digital C.R.PX817052026-04-09
03615020000014AKR 550AKR5502026-02-23
03615020000113CP 550CP5502026-02-23
03615020000441AKR 800AKR1JR2026-02-23
03615024000003Essilor StellestEmmetropia2025-10-16
03615024000034Essilor StellestMyopia+Astigmatism2025-10-16
03615020000458WAVE ANALYZER MEDICA 800WAM8002023-07-25
03615020000380WAVE ANALYZER MEDICA 700 PLUSWAM7002016-09-23
03615020000267ESSILOR RETINA 400RETINA 4002016-09-23
03615020000465ESSILOR RETINA 800RET1IN2020-04-02
03615020000489OCT500OCT2JT2020-03-23
03615020000038ALM500ALM5002023-10-03
03615020000120ALM700ALM7002023-10-03
03615020000236ALM800ALM8002023-10-03
03615020000670Vision-C 600VRS0012023-09-28
03615020000427Vision-R 800V010122023-09-11
03615020000663Vision-R 700V011122023-09-11
03615020000687Vision-S 700VS010122023-09-11
03615020000694Vision-R 800V010142023-09-11
03615020000724Vision-R 700V011142023-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03615024000003Essilor StellestESSILOR INTERNATIONALQUR2025-10-16
03615024000034Essilor StellestESSILOR INTERNATIONALQUR2025-10-16