510(k) DEN250016
- Device
- Essilor® Stellest®
- Applicant
- Essilor Of America, Inc.
- 510(k) number
- DEN250016
- Product code
- QUR
- Decision
- Unknown (DENG)
- Decision date
- 2025-09-25
- Date received
- 2025-04-28
- Regulation
- 886.5845
- Classification name
- Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- John Anderson
- Address
- 13455 Branchview Ln. Dallas TX US 75234 75234
FDA Registration Numbers
- 1624788
- 3003291784
- 3038269608
- 1215866
Source Documents
510(k) summary PDF not indicated by FDA