L-SER KO LAMP— 510(k) K112016

Substantially Equivalent

Ya-Man, Ltd.

FDA 510(k) clearance K112016 for L-SER KO LAMP, Substantially Equivalent on 2012-02-10. Applicant: Ya-Man, Ltd..

Clearance details

Applicant: Ya-Man, Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2011-07-14
Decision date: 2012-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, 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.