FDA product code SDE: Light Based Device For Dry Age-Related Macular Degeneration

SDE is the FDA product code for light based device for dry age-related macular degeneration. It is a Class II device, regulated under 21 CFR 886.5520 and reviewed by the Ophthalmic panel. Devices under SDE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for SDE devices, 1 initiated in the last five years.

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.

Classification

Recalls for SDE devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-07.

Frequently asked questions

What is FDA product code SDE?

SDE is the FDA product code for light based device for dry age-related macular degeneration. It is a Class II device, regulated under 21 CFR 886.5520 and reviewed by the Ophthalmic panel.

What device class is SDE?

Class II, regulation 21 CFR 886.5520. Typical premarket route: 510(k).

Have SDE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2025-05-07.

Next steps

• Run an FDA pathway report with predicate devices for product code SDE
• Run a recall and safety report across every SDE manufacturer
• Watch product code SDE for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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