Light Based Device For Dry Age-Related Macular Degeneration

SDE · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5520

Classification

FDA Product Code: SDE
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 886.5520
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown