LUCIA— 510(k) K102375

Substantially Equivalent

Meridian Co., Ltd.

FDA 510(k) clearance K102375 for LUCIA, Substantially Equivalent on 2011-02-25. Applicant: Meridian Co., Ltd..

Clearance details

Applicant: Meridian Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2010-08-20
Decision date: 2011-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.