L1 SYSTEM— 510(k) K024170

Name: FDA 510(k) clearance K024170
Creator: U.S. Food and Drug Administration
Published: 2003-04-14

Substantially Equivalent

Pelikan Technologies, Inc.

FDA 510(k) clearance K024170 for L1 SYSTEM, Substantially Equivalent on 2003-04-14. Applicant: Pelikan Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Pelikan Technologies, Inc.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2002-12-18
Decision date: 2003-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.