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Stellest

by Essilor Of America, Inc.

De Novo DEN250016

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN250016 Date25 Sep 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

Full name
Essilor® Stellest®
De Novo Number
FDA Product Code
QUR
Device Class
Class II
Regulation
21 CFR Part 886.5845
Advisory Committee
Ophthalmic
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Stellest is a prescription spectacle lens designed to reduce the progression of myopia in children, classified as a Class II medical device under FDA regulations (21 CFR 886.5845). These lenses incorporate a specialized optical design to help manage myopia development, supported by clinical evidence from a prospective, randomized trial in pediatric patients aged 6–12 years.

Supplied as single-use or reusable spectacle lenses, Stellest is intended for use in ophthalmic settings and requires proper fitting and follow-up care. The device carries FDA 510(k) clearance (K250016) and is distributed under regulatory oversight for myopia management. Storage and handling follow standard ophthalmic lens protocols, with no specific MRI safety restrictions noted.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Essilor® Stellest® lenses, and who is the intended user group?

    The Essilor® Stellest® lenses are designed specifically to help reduce the progression of myopia (nearsightedness) in children. Based on clinical evidence from a randomized trial, they are intended for pediatric patients aged 6 to 12 years. These lenses incorporate a specialized optical design to support myopia management, requiring proper fitting and follow-up care in an ophthalmic setting.

  • Are the Essilor® Stellest® lenses single-use or reusable, and how should they be stored?

    The Essilor® Stellest® lenses are supplied as either single-use or reusable spectacle lenses. Storage follows standard ophthalmic lens protocols, though no specific MRI safety restrictions are noted. Proper handling and adherence to typical ophthalmic lens care guidelines are recommended to maintain performance and safety.

  • What regulatory pathway was followed for FDA clearance of the Essilor® Stellest® lenses, and who can contact Essilor for additional details?

    The Essilor® Stellest® lenses received FDA clearance through a 510(k) submission (K250016), classified under the product code QUR for ophthalmic devices. For further inquiries, you may contact Essilor Of America, Inc. at their Dallas office, with John Anderson listed as a point of contact.

  • Are there any size or model variations available for the Essilor® Stellest® lenses, and how are they categorized?

    The Essilor® Stellest® lenses are categorized under the FDA’s product code QUR for prescription spectacle lenses designed to reduce myopia progression. While specific size or model variations are not detailed in the regulatory data, they are intended for general pediatric use within the 6–12 age range and follow standard ophthalmic lens specifications for fitting.