510(k) DEN230083
- Device
- Valeda Light Delivery System
- Applicant
- Lumithera, Inc.
- 510(k) number
- DEN230083
- Product code
- SDE
- Decision
- Unknown (DENG)
- Decision date
- 2024-11-04
- Date received
- 2023-12-14
- Regulation
- 886.5520
- Classification name
- Light Based Device For Dry Age-Related Macular Degeneration
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lori Holder
- Address
- 19578 10th Ave. NE Suite 200 Poulsbo WA US 98370 98370
FDA Registration Numbers#
- 3004186703
- 2133810
- 3016232028
Source Documents#
510(k) summary PDF not indicated by FDA