DeviceClearance

Product code SDE— Ophthalmic

Valeda Light Delivery System

Classification name
Light Based Device For Dry Age-Related Macular Degeneration
Device class
Class 2
Regulation
21 CFR 886.5520
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SDE under 21 CFR 886.5520, via openFDA

Market context for product code SDE

FDA has cleared 1 device under product code SDE, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SDE

Recent clearances under product code SDE

Data sourced from openFDA. This site is unofficial and independent of the FDA.