SDE — Light Based Device For Dry Age-Related Macular Degeneration Class II
FDA product code SDE covers "Light Based Device For Dry Age-Related Macular Degeneration", a Class II medical device regulated under 21 CFR 886.5520. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDE
- Device Class
- Class II
- Regulation Number
- 886.5520
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230083 | lumithera | Valeda Light Delivery System | November 4, 2024 |