Product code SDE

Device name

Light Based Device For Dry Age-Related Macular Degeneration

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5520

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset