Product Code: QUR
FDA class 2
21 CFR 886.5845
Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Ophthalmic
510(k)s
1
FEI Numbers
4
Registration Numbers
4
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- QUR
- Device Class
- FDA class 2
- Regulation Number
- 886.5845
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN250016 | Essilor® Stellest® | Sep 25, 2025 | Unknown | Essilor Of America, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.