Essilor® Stellest®
FDA 510(k) clearance DEN250016 · decided 2025-09-25
Clearance details
- K-number
- DEN250016
- Device name
- Essilor® Stellest®
- Applicant
- Essilor Of America, Inc.
- Decision
- Unknown
- Date received
- 2025-04-28
- Decision date
- 2025-09-25
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- QUR
- Device class
- 2
- Regulation number
- 886.5845
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.