SDE · Class II · 21 CFR 886.5520

FDA Product Code SDE: Light Based Device For Dry Age-related Macular Degeneration

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.

Leading manufacturers include Lumithera, Inc..

1
Total
0
Cleared
326d
Avg days
2024
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Light Based Device For Dry Age-related Macular Degeneration Devices (Product Code SDE)

1 devices
1–1 of 1
Not Cleared Nov 04, 2024
Valeda Light Delivery System
DEN230083
Lumithera, Inc.
Ophthalmic · 326d

About Product Code SDE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SDE since 2024, with 0 receiving FDA clearance (average review time: 326 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SDE devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →