LITECURE THERAPY COMPACT— 510(k) K121487

Substantially Equivalent

Litecure, LLC

FDA 510(k) clearance K121487 for LITECURE THERAPY COMPACT, Substantially Equivalent on 2012-06-12. Applicant: Litecure, LLC.

Clearance details

Applicant: Litecure, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2012-05-18
Decision date: 2012-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, 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.