510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SDEClass II

Light Based Device For Dry Age-Related Macular Degeneration

21 CFR 886.5520 / Ophthalmic
FDA source (opens on fda.gov)

SDE is the FDA product code for Light Based Device For Dry Age-Related Macular Degeneration, a class II device type, regulated under 21 CFR 886.5520. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
SDE
Device name
Light Based Device For Dry Age-Related Macular Degeneration
FDA 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.
Regulation
21 CFR 886.5520
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code SDE

By decision year
1 clearance under product code SDE with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SDE by decision year
YearClearances
20241

Applicants with the most clearances

Product code SDE
Applicants holding the most 510(k) clearances under product code SDE
ApplicantClearances
Lumithera, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code