# DEN230083: Valeda Light Delivery System

- Pathway: De Novo (Direct)
- Applicant: Lumithera, Inc.
- Decided: Nov 4, 2024 after 326 days
- Product code: SDE (Light Based Device For Dry Age-Related Macular Degeneration)
- Device class: 2
- Regulation: 21 CFR 886.5520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by: • The presence of at least 3 medium drusen (> 63 µm and ≤ 125 µm in diameter), or large drusen (> 125 µm in diameter), or non-central geographic atrophy, AND • The absence of neovascular maculopathy or center-involving geographic atrophy. After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.

Source page: https://510kreport.com/device/DEN230083
Methodology: https://510kreport.com/methodology