LUCO HYBRID OSA APPLIANCE— 510(k) K130797

Name: FDA 510(k) clearance K130797
Creator: U.S. Food and Drug Administration
Published: 2013-12-18

Substantially Equivalent

Luco Hybrid Osa Appliance, Inc.

FDA 510(k) clearance K130797 for LUCO HYBRID OSA APPLIANCE, Substantially Equivalent on 2013-12-18. Applicant: Luco Hybrid Osa Appliance, Inc.. Device class: 2.

Clearance details

Applicant: Luco Hybrid Osa Appliance, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2013-03-22
Decision date: 2013-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.