Valeda Light Delivery System
FDA 510(k) clearance DEN230083 · decided 2024-11-04
Clearance details
- K-number
- DEN230083
- Device name
- Valeda Light Delivery System
- Applicant
- Lumithera, Inc.
- Decision
- Unknown
- Date received
- 2023-12-14
- Decision date
- 2024-11-04
- Days to decision
- 326 days
- Clearance type
- Direct
- Product code
- SDE
- Device class
- 2
- Regulation number
- 886.5520
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Poulsbo, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.