FDA Device Intelligence
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Transilluminator (Diaphanoscope)

FDA product code LEK · Class 3 · Radiology

0
Registered devices
3
Adverse events
1
Recalls
0
510(k) clearances

Recent recalls

DateFirmReason
2024-05-20Silkprousa LLCFirm is marketing and distributing the Pink Luminous Breast device without premarket approval

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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.