DTL 2

DIAGNOSYS LLC · Model D141 · UDI-DI 00855730007429

510(k) clearances

Adverse events

Recalls

Facilities

Description

A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.