NAVILAS LASER SYSTEM— 510(k) K141851

Substantially Equivalent

Od-Os GmbH

FDA 510(k) clearance K141851 for NAVILAS LASER SYSTEM, Substantially Equivalent on 2015-01-02. Applicant: Od-Os GmbH.

Clearance details

Applicant: Od-Os GmbH
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2014-07-09
Decision date: 2015-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.