SDE

Light Based Device For Dry Age-Related Macular Degeneration

Product code

SDE

Device name

Light Based Device For Dry Age-Related Macular Degeneration

Device class

Class 2

21 CFR

21 CFR 886.5520

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-11-04.