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Light Based Device For Dry Age-Related Macular Degeneration

FDA product code SDE · Class 2 · Ophthalmic

1
Registered devices
4
Adverse events
1
Recalls
1
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-05-07LUMITHERA INCU.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.