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Earlens Fitting Software, USB

EARLENS CORPORATION · Model ELF002 · UDI-DI 00850013007295

PLK
1
510(k) clearances
3
Adverse events
0
Recalls
1
Facilities

Description

Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).

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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.