Light Based Device For Dry Age-Related Macular Degeneration
A light-based device for dry age-related macular degeneration is a prescription ophthalmic device intended to apply non-coherent light energy to the eye to treat or improve visual acuity in patients with dry age-related macular degeneration, a leading cause of vision loss in older adults. It is classified as FDA Class II (510(k) required) under regulation 886.5520 in the Ophthalmic specialty, with product code SDE. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SDE
- Device Class
- FDA class 2
- Regulation Number
- 886.5520
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230083 | Valeda Light Delivery System | Nov 04, 2024 | Unknown | Lumithera, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.