SDE · Light Based Device For Dry Age-Related Macular Degeneration
Ophthalmic · 21 CFR 886.5520 · Class 2
Overview
| Product Code | SDE |
|---|---|
| Device Name | Light Based Device For Dry Age-Related Macular Degeneration |
| Regulation | 21 CFR 886.5520 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
The Valeda Light Delivery System is a prescription, benchtop instrument intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 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. The device applies non-coherent light energy to the eye using three light-emitting diodes (LEDs) at 590 nm (amber), 660 nm (red), and 850 nm (near-infrared).
Classification Rationale
Class II (special controls). The device is granted under the De Novo classification process, with the determination that the probable benefits outweigh the probable risks, and that the risks can be mitigated by the use of general and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the light based device for dry agerelated macular degeneration is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230083 | Valeda Light Delivery System | Lumithera, Inc. | Nov 4, 2024 | DENG |
Top Applicants
- Lumithera, Inc. — 1 clearance
