SDE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Light Based Device For Dry Age-Related Macular Degeneration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5520
- Medical specialty
- Ophthalmic
- FDA definition
- A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration.
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| Record | Firm | Date |
|---|---|---|
| Valeda Light Delivery System (DEN230083) | Lumithera, Inc. | 2024-11-04 |
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